AESCULAP NN260PRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 04046963711320), received between Sep 15, 2020 and Jan 19, 2023 — classified as 34 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (31 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• InjuryJan 19, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INVESTIGATION COMPLETE.

  Patient problems: Failure of Implant

  MAUDE report 16207523 ↗
• InjuryJan 19, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT A PLUG F/TIBIAL PLATEAU (ITEM NN260P) WAS IMPLANTED DURING A LEFT TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, ASEPTIC LOOSENING OF AESCULAP VEGA CEMENTED TOTAL KNEE REPLACEMENT WITH-DE-BONDING OF THE IMPLANT FROM THE CEMENT MANTLE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION SURGERY. THE ADVERSE EVENT/MALFUNCTION IS FILED UNDER AIC REFERENCE XC 100032170 CC 400582824: ASSOCIATE MEDWATCH REPORTS 400582825_2916714-2023-00007_MDR, 400582826_2916714-2023-00008_MDR, 400582827_2916714-2023-00009_MDR, 400582828_2916714-2023-00010_MDR.

  Patient problems: Failure of Implant

  MAUDE report 16206246 ↗
• InjuryApr 9, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A KNEE IMPLANT SYSTEM. IT WAS REPORTED ON (B)(6) 2017, THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED KNEE PAIN, DIFFICULTY WALKING AND LOOSENING OF THE IMPLANT WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2014 AND THE REVISION SURGERY OCCURRED ON (B)(6) 2017. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: NX009Z (PS FEMUR CEMENTED F4N LT), NX053Z (PS TIBIA CEMENTED T2), NN260P (PEEK PLUG F/TIBIA), NX042 (UNIVERSAL PATELLA P2), AE-QAS-K521-99(COLLECT.NO.QAS KNEE IMPL.MISC./UNKNOWN). ASSOCIATED MEDWATCHES: 2916714-2020-00384, 2916714-2020-00385, 2916714-2020-00387, 2916714-2020-00388.

  Patient problems: Ambulation or Postural Difficulties; Implant Pain; Joint Laxity

  MAUDE report 11640960 ↗
• InjuryApr 1, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A KNEE IMPLANT SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, DIFFICULTY WALKING, AND LOOSENING OF THE IMPLANT. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013 AND THE REVISION SURGERY OCCURRED (B)(6) 2018. A REVISION SURGERY WAS NECESSARY. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE REPORT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT IS FILED UNDER XC REFERENCE (B)(4). INVOLVED COMPONENTS: NX132 - VEGA PS GLIDING SURFACE T3/3+ 14MM - LOT 51949663. NN260P - PLUG F/TIBIAL PLATEAU - LOT 51974495. NX013Z - AS VEGA PS FEMORAL COMP.CEMENTED F6N L - LOT 51927043. NX055Z (PS TIBIA CEMENTED T3); - LOT 51938561. NX044 - PATELLA 3-PEGS P4 - LOT51911583. CEMENT USED IS UNIDENTIFIED. ASSOCIATED MEDWATCHES: 2916714-2020-00307. 2916714-2020-00309. 2916714-2020-00310. 2916714-2020-00311.

  Patient problems: Ambulation or Postural Difficulties; Implant Pain; Joint Laxity

  MAUDE report 11604250 ↗
• InjuryApr 1, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A KNEE IMPLANT SYSTEM. IT WAS REPORTED ON (B)(6) 2018, THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED KNEE PAIN, DIFFICULTY WALKING AND LOOSENING OF THE IMPLANT WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2011 AND THE REVISION SURGERY OCCURRED ON (B)(6) 2012. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT IS FILED UNDER (B)(4). INVOLVED COMPONENTS: NN165K (COLUMBUS PS FEMUR SZ 5 LEFT), NN075K (COLUMBUS CR MODULAR TIBIA SZ 3), NN260P (PEEK PLUG F/TIBIA), NN482 (COLUMBUS PRI/REV PE PATELLA 3-PEGS P2), NN531 (COLUMBUS PS TIBIAL INSERT SZ 3/3+ 12MM). CEMENT USED: ZIMMER PALACOS R RADIOPAQUE BONE CEMENT. THE PRIMARY SURGERY WAS PERFORMED WITHOUT AS TECHNOLOGY. ASSOCIATED MEDWATCHES: 2916714-2020-00370, 2916714-2020-00371, 2916714-2020-00372, 2916714-2020-00373, 2916714-2020-00374.

  Patient problems: Ambulation or Postural Difficulties; Implant Pain; Joint Laxity

  MAUDE report 11602230 ↗
• InjuryMar 19, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT A VEGA KNEE IMPLANT SYSTEM WAS IMPLANTED DURING A PRIMARY SURGERY PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED LOOSENING OF THE IMPLANT. THE PATIENT UNDERWENT A REVISION SURGERY OCCURRED ON (B)(6) 2017. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE XC (B)(4). INVOLVED COMPONENTS: NX009Z (PS FEMUR CEMENTED F4N LT), NX043 (UNIVERSAL PATELLA P3), NX110 (PS PE INSERT T1/T1+, 10MM), NN260P (PEEK PLUG F/ TIBIA), NX051Z (PS TIBIA CEMENTED T1). THE CEMENT USED IS UNIDENTIFIED. ASSOCIATED MEDWATCHES: 2916714-2020-00329, 2916714-2020-00330, 2916714-2020-00331, 2916714-2020-00333.

  Patient problems: Joint Laxity

  MAUDE report 11528973 ↗
• InjuryMar 8, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO AESCULAP INC. THAT A VEGA KNEE IMPLANT SYSTEM WAS IMPLANTED DURING A PRIMARY SURGERY PERFORMED ON (B)(4) 2014. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED PAIN AND DIFFICULTY IN WALKING OF THE IMPLANT. THE PATIENT UNDERWENT A REVISION SURGERY OCCURRED ON (B)(6) 2015. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT MALFUNCTION IS FILED UNDER REFERENCE XC (B)(4). INVOLVED COMPONENTS. NN260P PEEK PLUG F TIBIA NX053Z PS TIBIA CEMENTED T2 NX042 UNIVERSAL PATELLA P2 NX031Z PS FEMUR CEMENTED F5N RT NX121 PS PE INSERT T2/T2+, 12MM THE CEMENT USED IS UNIDENTIFIED. ASSOCIATED MEDWATCHES: 2916714-2020-00320, 2916714-2020-00321, 2916714-2020-00322, 2916714-2020-00323.

  Patient problems: Ambulation or Postural Difficulties; Implant Pain

  MAUDE report 11438851 ↗
• InjuryMar 8, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH VEGA KNEE IMPLANT(S). IT WAS REPORTED ON (B)(6) 2018. THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PATIENT EXPERIENCED PAIN, SWELLING, DIFFICULTY WALKING, AND LOOSENING OF THE IMPLANT WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013, AND THE REVISION SURGERY OCCURRED ON (B)(6) 2015. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME; IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT IS FILED UNDER XC REFERENCE (B)(4). INVOLVED COMPONENTS: NX053Z (AS VEGA PS TIBIAL PLATEAU ), NX031Z (PS FEMUR CEMENTED F5N RT), NX121 (PS PE INSERT T2/T2+, 12MM), NN260P (PEEK PLUG F/ TIBIA), NX043 (UNIVERSAL PATELLA P3), THE CEMENT USED WAS UNKNOWN ASSOCIATED MEDWATCHES: 2916714-2020-00324, 2916714-2020-00325, 2916714-2020-00326, 2916714-2020-00328.

  Patient problems: Ambulation or Postural Difficulties; Implant Pain; Swelling/ Edema

  MAUDE report 11436259 ↗
• InjuryMar 4, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT A VEGA KNEE IMPLANT SYSTEM WAS IMPLANTED DURING A PRIMARY SURGERY PERFORMED ON (B)(6) 2013 (LEFT) (B)(6) 2013 (RIGHT). ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED PAIN SWELLING, DIFFICULTY WALKING AND LOOSENING OF THE IMPLANT, WHICH RESULTED IN A LEFT KNEE REVISION SURGERY. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2015 LEFT KNEE. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). INVOLVED COMPONENTS: NX013Z (PS FEMUR CEMENTED F6N LT). NX055Z (PS TIBIA CEMENTED T3). NN260P (PEEK PLUG F/ TIBIA). NX044 (UNIVERSAL PATELLA P4). NX130 (PS PE INSERT T3/T3+, 10MM). ASSOCIATED MEDWATCHES: 2916714-2020-00355, 2916714-2020-00356, 2916714-2020-00358, 2916714-2020-00359.

  Patient problems: Ambulation or Postural Difficulties; Implant Pain; Joint Laxity; Swelling/ Edema

  MAUDE report 11415186 ↗
• InjuryFeb 25, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO AESCULAP INC. THAT A VEGA KNEE IMPLANT SYSTEM WAS IMPLANTED DURING A PRIMARY SURGERY PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED PAIN AND DIFFICULTY WALKING OF THE IMPLANT. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE XC (B)(4). INVOLVED COMPONENTS: NX007Z (PS FEMUR CEMENTED F3N LT); NN260P (PEEK PLUG F/ TIBIA); NX049Z (PS TIBIA CEMENTED T0); NX042 (UNIVERSAL PATELLA P2); NX102 (PS PE INSERT T0/T0+, 14MM). CEMENT USED IS UNKNOWN. ASSOCIATED MEDWATCHES: 2916714-2020-00312, 2916714-2020-00313, 2916714-2020-00314, 2916714-2020-00315, 2916714-2020-00316.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 11381586 ↗
• InjuryFeb 19, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A VEGA KNEE COMPONENTS. IT WAS REPORTED ON (B)(6) 2018, THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED PAIN, DIFFICULTY WALKING AND LOOSENING OF THE IMPLANT, WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013 AND THE REVISION SURGERY OCCURRED ON (B)(6) 2018. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). INVOLVED COMPONENTS: NX031Z (PS FEMUR CEMENTED F5N RT), NX053Z (PS TIBIA CEMENTED T2), NN260P (PEEK PLUG F/ TIBIA), NX043 (UNIVERSAL PATELLA P3), NX123 (PS PE INSERT T2/T2+, 16MM). ASSOCIATED MEDWATCHES: 2916714-2020-00349 2916714-2020-00350 2916714-2020-00352 2916714-2020-00353.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11348642 ↗
• InjuryJan 28, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT AN VEGA KNEE IMPLANT SYSTEM, COMPRISED OF THE FOLLOWING COMPONENTS, VEGA SYSTEM PS FEMUR F5N R (PART #NX031Z) (REF. ASSOCIATED MDR ID 2916714-2020-00624), VEGA SYSTEM PATELLA 3-PEG SIZE P3 (PART # NX043) (REF. ASSOCIATED MDR ID 2916714-2020-00625), VEGA SYSTEM PS TIBIA PLATEAU T1, CEMENTED IMPLANT (PART # NX051Z) (REF. ASSOCIATED MDR ID 2916714-2020-00626), VEGA SYSTEM PS GLIDING SURFACE IMPLANT 14MM T1/T1+ (PART # NX112) (REF. ASSOCIATED MDR ID 2916714-2020-00627), AND A VEGA SYSTEM PEEK PLUG T1-T5 (PART # NN260P), WAS IMPLANTED DURING A PRIMARY SURGERY PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED PAIN AND SWELLING IN IN THE RIGHT KNEE, WHICH RESTRICTED ROUTINE DAILY ACTIVITIES. THE PATIENT UNDERWENT A REVISION SURGERY PERFORMED ON (B)(6) 2018. THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S IMPLANT. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY REVEALED LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS. NO COMPONENTS WERE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO KNOWN ADVERSE PATIENT EFFECTS OCCURRED AS A RESULT OF THE REVISION SURGERY. ADDITIO

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 11248052 ↗
• InjuryJan 21, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A VEGA KNEE COMPONENTS. AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED PAIN, SWELLING IN RIGHT KNEE AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO PAIN. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY TO RIGHT KNEE WERE LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013 AND THE REVISION SURGERY OCCURRED ON (B)(6) 2016. THE CEMENT USED DURING PROCEDURE IS UNAVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE XC (B)(4). INVOLVED COMPONENTS: NX033Z(PS FEMUR CEMENTED F6N RT), NX043 (UNIVERSAL PATELLA P3), NX053Z (PS TIBIA CEMENTED T2), NX120 (PS PE INSERT T2/T2+, 10MM), NN260P(PEEK PLUG F/ TIBIA). ASSOCIATED MEDWATCHES: 2916714-2020-00655, 2916714-2020-00656, 2916714-2020-00657, 2916714-2020-00658, 2916714-2020-00659.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 11210699 ↗
• InjuryJan 5, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A VEGA KNEE COMPONENTS. AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED PAIN, SWELLING IN THE LEFT KNEE AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO PAIN. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY WERE LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS, WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013 AND THE REVISION SURGERY OCCURRED ON (B)(6) 2018. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). INVOLVED COMPONENTS: NX009Z (PS FEMUR CEMENTED F4N LT), NX042 (UNIVERSAL PATELLA P2), NX051Z (PS TIBIA CEMENTED T1), NX112 (PS PE INSERT T1/T1+, 14MM), NN260P (PEEK PLUG F/ TIBIA). CEMENT USED: ZIMMER PALACOS R RADIOPAQUE BONE CEMENT. ASSOCIATED MEDWATCHES: 2916714-2020-00619, 2916714-2020-00620, 2916714-2020-00621, 2916714-2020-00622.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 11120513 ↗
• InjuryJan 5, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AS VEGA KNEE, RIGHT SIDE. IT WAS REPORTED THAT AS A RESULT OF HAVING THE PRODUCTS IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN AND SWELLING; AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO THE PAIN. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013 AND THE REVISION OCCURRED ON (B)(6) 2016. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY WERE LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS WHICH RESULTED IN THE REVISION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NX033Z (PS FEMUR CEMENTED F6N RT), NX044 (UNIVERSAL PATELLA P4), NX055Z (PS TIBIA CEMENTED T3), NX132 (PS PE INSERT T3/T3+, 14MM), NN260P (PEEK PLUG F/ TIBIA). THE CEMENT USED WAS ZIMMER PALACOS R RADIOPAQUE BONE CEMENT. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00511, 2916714-2020-00512, 2916714-2020-00513, 2916714-2020-00514.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema; Synovitis

  MAUDE report 11118503 ↗
• InjuryJan 5, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A VEGA KNEE COMPONENTS. AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED PAIN, SWELLING IN THE RIGHT KNEE AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO PAIN. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY WERE LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS, WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) C2013 AND THE REVISION SURGERY OCCURRED ON (B)(6) 2018. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). INVOLVED COMPONENTS: NX031Z(PS FEMUR CEMENTED F5N RT), NX043 (UNIVERSAL PATELLA P3), NX053Z (PS TIBIA CEMENTED T2), NX121(PS PE INSERT T2/T2+, 12MM), NN260P(PEEK PLUG F/TIBIA). CEMENT USED: ZIMMER PALACOS R RADIOPAQUE BONE CEMENT. ASSOCIATED MEDWATCHES: 2916714-2020-00639, 2916714-2020-00640, 2916714-2020-00641, 2916714-2020-00642.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11118444 ↗
• InjuryJan 5, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AS VEGA KNEE, LEFT SIDE. IT WAS REPORTED THAT AS A RESULT OF HAVING THE PRODUCTS IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN AND SWELLING; AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO THE PAIN. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013 AND THE REVISION OCCURRED ON (B)(6) 2018. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY WERE LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS WHICH RESULTED IN THE REVISION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NX013Z (PS FEMUR CEMENTED F6N LT), NX043 (UNIVERSAL PATELLA P3), NX055Z (PS TIBIA CEMENTED T3), NX131 (PS PE INSERT T3/T3+, 12MM), NN260P (PEEK PLUG F/ TIBIA). THE CEMENT USED WAS ZIMMER PALACOS R RADIOPAQUE BONE CEMENT. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00531, 2916714-2020-00532, 2916714-2020-00533, 2916714-2020-00534, 2916714-2020-00535.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema; Synovitis

  MAUDE report 11117886 ↗
• InjuryDec 22, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A VEGA KNEE COMPONENTS. AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED PAIN, SWELLING IN LEFT KNEE AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO PAIN. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY TO LEFT KNEE WERE LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013 AND THE REVISION SURGERY OCCURRED ON (B)(6) 2016. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). INVOLVED COMPONENTS: NX013Z(PS FEMUR CEMENTED F6N LT), NX043 (UNIVERSAL PATELLA P3), NX053Z (PS TIBIA CEMENTED T2), NX121 (PS PE INSERT T2/T2+, 12MM), NN260P(PEEK PLUG F/ TIBIA). ASSOCIATED MEDWATCHES: 2916714-2020-00650, 2916714-2020-00651, 2916714-2020-00652, 2916714-2020-00653.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 11058717 ↗
• InjuryDec 8, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A VEGA KNEE. THE PATIENT HAS EXPERIENCED PAIN AND SWELLING IN RIGHT KNEE, AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO THIS PAIN. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2012, AND THE REVISION SURGERY OCCURRED ON (B)(6) 2018. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY WERE LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS, WHICH HAD RESULTED IN A REVISION SURGERY. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NX031Z (PS FEMUR CEMENTED F5N RT), NX044 (UNIVERSAL PATELLA P4), NX055Z (PS TIBIA CEMENTED T3), NX130 (PS PE INSERT T3/T3+, 10MM), NN260P (PEEK PLUG F/ TIBIA). THE CEMENT USED WAS NOT SPECIFIED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00631, 2916714-2020-00632, 2916714-2020-00633, AND 2916714-2020-00634.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 10969770 ↗
• InjuryNov 11, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT AN VEGA KNEE IMPLANT SYSTEM, COMPRISED OF THE FOLLOWING COMPONENTS, VEGA SYSTEM PS FEMUR F5N R (PART #NX031Z) (REF. ASSOCIATED MDR ID 2916714-2020-00550), VEGA SYSTEM PATELLA 3-PEG SIZE P2 (PART # NX042) (REF. ASSOCIATED MDR ID 2916714-2020-00551), VEGA SYSTEM PS TIBIA PLATEAU T1, CEMENTED IMPLANT (PART # NX051Z) (REF. ASSOCIATED MDR ID 2916714-2020-00552), VEGA SYSTEM PS GLIDING SURFACE IMPLANT 14MM T1/T1+ (PART # NX112) (REF. ASSOCIATED MDR ID 2916714-2020-00553), AND A VEGA SYSTEM PEEK PLUG T1-T5 (PART # NN260P), WAS IMPLANTED DURING A PRIMARY SURGERY PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED PAIN AND SWELLING IN BOTH KNEES, WHICH RESTRICTED ROUTINE DAILY ACTIVITIES. THE PATIENT UNDERWENT A REVISION SURGERY PERFORMED ON (B)(6) 2016. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY REVEALED LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS. THE CEMENT USED DURING THE PRIMARY SURGERY IS UNKNOWN. NO KNOWN ADVERSE PATIENT EFFECTS OCCURRED AS A RESULT OF THE REVISION SURGERY. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONAL INFOR

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 10826167 ↗
• InjuryNov 10, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A VEGA KNEE. IT WAS REPORTED THAT AS A RESULT OF HAVING THE PRODUCTS IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN AND SWELLING IN BOTH KNEES; NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO THIS PAIN. THE PRIMARY PROCEDURE OCCURRED ON (B)(6) 2012, AND THE REVISION WAS PERFORMED ON (B)(6) 2016. INTRAOPERATIVE FINDINGS WERE LOOSENING OF THE TIBIAL AND FEMORAL COMPONENT. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NX031Z (PS FEMUR CEMENTED F5N RT), NX043 (UNIVERSAL PATELLA P3), NX054Z (PS TIBIA CEMENTED T2+), NX120 (PS PE INSERT T2/T2+, 10MM), NN260P (PEEK PLUG F/ TIBIA). THE CEMENT USED WAS NOT SPECIFIED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE XC (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00495, 2916714-2020-00496, 2916714-2020-00497, 2916714-2020-00498.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 10816397 ↗
• InjuryNov 10, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT AN VEGA KNEE IMPLANT SYSTEM, COMPRISED OF THE FOLLOWING COMPONENTS, VEGA SYSTEM PS FEMUR F5N R (PART #NX031Z) (REF. ASSOCIATED MDR ID 2916714-2020-00521), VEGA SYSTEM PATELLA 3-PEG SIZE P3 (PART # NX043) (REF. ASSOCIATED MDR ID 2916714-2020-00522), VEGA SYSTEM PS TIBIA PLATEAU T3, CEMENTED IMPLANT (PART # NX055Z) (REF. ASSOCIATED MDR ID 2916714-2020-00523), PS+ GLIDING SURFACE IMPLANT 10MM T3/T3+ (PART # NX130) (REF. ASSOCIATED MDR ID 2916714-2020-00524), AND A VEGA SYSTEM PEEK PLUG T1-T5 (PART # NN260P), WAS IMPLANTED DURING A PRIMARY SURGERY PERFORMED ON ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED PAIN AND SWELLING IN RIGHT KNEE, WHICH RESTRICTED ROUTINE DAILY ACTIVITIES. A SUBSEQUENT X-RAY SHOWED POSSIBLE LOOSENING OF THE TIBIAL COMPONENT AND A RADIOLUCENT LINE AROUND THE TIBIAL COMPONENT. BONE SCANS SHOWED AN INCREASED UPTAKE IN THE TIBIAL COMPONENT. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY WERE A WELL-FIXED PATELLAR COMPONENT AND LOSING OF THE TIBIAL AND FEMORAL COMPONENTS. THE CEMENT USED DURING THE PRIMARY SURGERY WAS IDENTIFIED AS ZIMMER PALACOS R RADIOPAQUE BONE CEMENT.

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 10815759 ↗
• InjuryNov 9, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH VEGA KNEE COMPONENTS. AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED PAIN AND SWELLING IN LEFT KNEE AND NORMAL DAILY ACTIVITIES WAS RESTRICTED DUE TO PAIN. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY WERE A WELL-FIXED PATELLAR COMPONENT AND LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS, WHICH RESULTED IN REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013 AND THE REVISION SURGERY OCCURED ON (B)(6) 2016. CEMENT USED: ZIMMER PALACOS R RADIOPAQUE BONE CEMENT. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). INVOLVED COMPONENTS: NX013Z (PS FEMUR CEMENTED F6N LT). NX043 (UNIVERSAL PATELLA P3). NX055Z (PS TIBIA CEMENTED T3). NX131(PS PE INSERT T3/T3+,12MM). NN260P (PEEK PLUG F/TIBIA). ASSOCIATED MEDWATCHES: 2916714-2020-00555. 2916714-2020-00556. 2916714-2020-00557. 2916714-2020-00558.

  Patient problems: Implant Pain; Joint Laxity; Swelling/ Edema

  MAUDE report 10809847 ↗
• InjuryNov 9, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AS VEGA KNEE, RIGHT SIDE. IT WAS REPORTED THAT AS A RESULT OF HAVING THE PRODUCTS IMPLANTED, THE PATIENT HAS EXPERIENCED KNEE PAIN AND SWELLING, AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO THE PAIN. THE PRIMARY PROCEDURE OCCURRED ON (B)(6) 2012, AND THE REVISION WAS PERFORMED ON (B)(6) 2018. INTRAOPERATIVE FINDINGS WERE REACTIVE SYNOVITIS WITH AREAS OF NECROTIC TISSUE AND LOOSENING OF THE FEMORAL COMPONENT . ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NX027Z (PS FEMUR CEMENTED F3N RT); NX042 (UNIVERSAL PATELLA P2); NX049Z (PS TIBIA CEMENTED T0); NX102 (PS PE INSERT T0/T0+, 14MM); NN260P (PEEK PLUG F/ TIBIA). THE CEMENT USED WAS BIOMET COBALT HV BONE CEMENT. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00605; 2916714-2020-00606; 2916714-2020-00607; 2916714-2020-00608.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema; Synovitis

  MAUDE report 10809193 ↗
• InjuryNov 6, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH VEGA KNEE COMPONENTS. AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED PAIN AND SWELLING IN LEFT KNEE AND NORMAL DAILY ACTIVITIES WAS RESTRICTED DUE TO PAIN. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY WERE A WELL-FIXED PATELLAR COMPONENT AND LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS, WHICH RESULTED IN REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013 AND THE REVISION SURGERY OCCURED ON (B)(6) 2016. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). INVOLVED COMPONENTS: NX009Z (PS FEMUR CEMENTED F4N LT), NX042 (UNIVERSAL PATELLA P2), NX049Z (PS TIBIA CEMENTED T0), NX103(PS PE INSERT T0/T0+,16MM), NN260P (PEEK PLUG F/TIBIA). ASSOCIATED MEDWATCHES: 2916714-2020-00500, 2916714-2020-00501, 2916714-2020-00502, 2916714-2020-00503.

  Patient problems: Implant Pain; Joint Laxity; Swelling/ Edema

  MAUDE report 10804655 ↗