AESCULAP NX043Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04046963810290), received between Sep 29, 2020 and Jun 8, 2026 — classified as 21 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (19 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED COMPLICATIONS WITH AN AESCULAP KNEE IMPLANT. REPORTEDLY THE FEMORAL COMPONENT WAS "GROSSLY LOOSE" AND "REMOVED BY HAND". THE TIBIAL COMPONENT WAS ALSO "GROSSLY LOOSE" AND "LIFTED OUT OF THE CEMENT MANTLE" THE CEMENT MANTLE REMAINED ADHERED TO THE BONES AND HAD TO BE EXTRACTED DURING THE REVISION SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED. THIS REPORT IS FILED UNDER AIS REFERENCE XC(B)(4).

  Patient problems: Failure of Implant

  MAUDE report 25431197 ↗
• InjuryOct 21, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATELLA 3-PEGS P3 (PART# NX043) WAS IMPLANTED IN A PATIENT'S RIGHT KNEE SOMETIME IN 2022. ACCORDING TO THE COMPLAINT DESCRIPTION, THE REVISION SURGERY WAS PLANNED FOR (B)(6) 2024. REPORTEDLY THE REASON FOR THE SURGERY WAS DUE TO A SCREW COMING LOSE IN THE CONSTRUCT, AS SUCH, THE IMPLANT WAS FLOATING AROUND IN THE JOINT. THE POLYETHYLENE COMPONENTS WOULD BE REMOVED AND REPLACED. THE ADVERSE EVENT IS FILED UNDER AESCULAP REFERENCE NUMBER (B)(4). 2916714-2024-00130 (AIC REFERENCE NO. (B)(4)), 2916714-2024-00149 (AIC REFERENCE NO. (B)(4)), 2916714-2024-00150 (AIC REFERENCE NO. (B)(4)).

  Patient problems: Failure of Implant

  MAUDE report 20494544 ↗
• 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 (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, 2916714-2020-00332, 2916714-2020-00333.

  Patient problems: Joint Laxity

  MAUDE report 11527605 ↗
• 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, 2916714-2020-00327.

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

  MAUDE report 11436235 ↗
• InjuryMar 5, 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 PAIN SWELLING, DIFFICULTY WALKING AND LOOSENING OF THE IMPLANT. AFTER FIRST REVISION SURGERY, PATIENT CONTINUED TO EXPERIENCE PAIN, SWELLING, DIFFICULTY WALKING AND LOOSENING OF THE IMPLANT, WHICH RESULTED IN A SECOND REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2015 WITH FIRST REVISION IN (B)(6) 2015, WITH ANOTHER VEGA IMPLANT. THE SECOND REVISION SURGERY OCCURRED ON (B)(6) 2017, WITH AN UNIDENTIFIED NON-AESCULAP IMPLANT.. 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: NX030Z (PS FEMUR CEMENTED F4 RT) NN264Z (TIBIAL OBTURATOR D14MM, L7MM) NX043 (UNIVERSAL PATELLA P3) NX056Z (PS TIBIA CEMENTED T3+) NX132 (PS PE INSERT T3/T3+, 14MM) THE COMPONENTS LISTED ARE RELATED TO THE PRIMARY SURGERY. IT IS UNKNOWN EXACTLY WHICH COMPONENTS WERE REPLACED IN THE FIRST AND SECOND REVISION SURGE

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

  MAUDE report 11424003 ↗
• InjuryFeb 26, 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 PS KNEE COMPONENTS. AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED KNEE PAIN, SWELLING, DIFFICULTY WALKING, AND LOOSENING AND INSTABILITY OF THE IMPLANT WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY PROCEDURE OCCURRED ON (B)(6) 2014, AND THE REVISION 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 XC REFERENCE (B)(4). INVOLVED COMPONENTS: NN261Z (TIBIAL OBTURATOR D12MM, L7MM), NX043 (UNIVERSAL PATELLA P3), NX222 (PS PE INSERT T2/T2+, 14MM), NX009Z (PS FEMUR CEMENTED F4N LT). CEMENT USED: ZIMMER PALACOS R RADIOPAQUE BONE CEMENT. ASSOCIATED MEDWATCHES: 2916714-2020-00422, 2916714-2020-00423, 2916714-2020-00425, 2916714-2020-00426.

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

  MAUDE report 11387824 ↗
• 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 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 XC (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, 2916714-2020-00351, 2916714-2020-00353.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11348688 ↗
• 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), 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) (REF. ASSOCIATED MDR ID 2916714-2020-00628), 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 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. ADDI

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 11248036 ↗
• 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 (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 11210414 ↗
• 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) 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), 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, 2916714-2020-00641, 2916714-2020-00642, 2916714-2020-00643.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11117973 ↗
• 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, 2916714-2020-00533, 2916714-2020-00534, 2916714-2020-00535.

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

  MAUDE report 11117885 ↗
• InjuryJan 4, 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 KNEE PAIN, NUMBNESS AND LOOSENING AND INSTABILITY OF THE IMPLANT. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2014 AND THERE WAS NO REPORTED REVISION SURGERY. 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: NX031Z (PS FEMUR CEMENTED F5N RT). NN261Z (TIBIAL OBTURATOR D12MM, L7MM). NX053Z (PS TIBIA CEMENTED T2). NX043 (UNIVERSAL PATELLA P3). NX120 (PS PE INSERT T2/T2+, 10MM). ASSOCIATED MEDWATCHES: 2916714-2020-00660, 2916714-2020-00661, 2916714-2020-00662, 2916714-2020-00664.

  Patient problems: Joint Laxity; Numbness; Pain

  MAUDE report 11113470 ↗
• 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, 2916714-2020-00652, 2916714-2020-00653, 2916714-2020-00654.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 11058032 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 DIFFICULTY WALKING. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2015 AND THERE WAS NO REPORTED REVISION SURGERY. 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: NX011Z(PS FEMUR CEMENTED F5N LT), NX043 (UNIVERSAL PATELLA P3), NX055Z (PS TIBIA CEMENTED T3), NX130 (PS PE INSERT T3/T3+, 10MM), NN261Z(TIBIAL OBTURATOR D12MM, L7MM). THE CEMENT USED IS UNIDENTIFIED. ASSOCIATED MEDWATCHES: 2916714-2020-00249, 2916714-2020-00251, 2916714-2020-00252, 2916714-2020-00253.

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

  MAUDE report 11014061 ↗
• InjuryDec 15, 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 KNEE PAIN, SWELLING AND LOSS OF MOBILITY 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 / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). INVOLVED COMPONENTS: NX043 (UNIVERSAL PATELLA P3), NX030Z(PS FEMUR CEMENTED F4 RT), NX230 (PS PE INSERT T3/T3+, 10MM), NX055Z (PS TIBIA CEMENTED T3), NX062Z(TIBIAL STEM CEMENTED 12X52MM). THE CEMENT USED IS UNIDENTIFIED. ASSOCIATED MEDWATCHES: 2916714-2020-00287, 2916714-2020-00288, 2916714-2020-00289, 2916714-2020-00290.

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

  MAUDE report 11007778 ↗
• 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 100026350. ASSOCIATED MEDWATCHES: 2916714-2020-00495, 2916714-2020-00497, 2916714-2020-00498, 2916714-2020-00499.

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

  MAUDE report 10816408 ↗
• 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), 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) (REF. ASSOCIATED MDR ID 2916714-2020-00525), 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 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. TH

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 10815753 ↗
• 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; 2916714-2020-00557; 2916714-2020-00558; 2916714-2020-00559.

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

  MAUDE report 10809672 ↗
• 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 A VEGA KNEE COMPONENTS. AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED KNEE PAIN AND SWELLING IN RIGHT KNEE AND NORMAL DAILY ACTIVITIES WAS RESTRICTED DUE TO PAIN. A SUBSEQUENT X-RAY SHOWED POSSIBLE LOOSENING OF THE TIBIAL COMPONENT AND A RADIOLUCENT LINE AROUND THE TIBIAL COMPONENT. DURING REPLACEMENT SURGERY INTRAOPERATIVE FINDINGS WERE 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: NX031Z (PS FEMUR CEMENTED F5N RT), NX043 (UNIVERSAL PATELLA P3), NX051Z (PS TIBIA CEMENTED T1), NX112(PS PE INSERT T1/T1+,14MM), NN260P (PEEK PLUG F/TIBIA). ASSOCIATED MEDWATCHES: 2916714-2020-00516, 2916714-2020-00518, 2916714-2020-00519, 2916714-2020-00520.

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

  MAUDE report 10803497 ↗
• InjuryOct 15, 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. IT WAS REPORTED THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED KNEE PAIN, SWELLING, DIFFICULTY WALKING, AND LOOSENING AND INSTABILITY OF THE DEVICE. THE PRIMARY PROCEDURE OCCURRED ON (B)(6) 2014, AND THE REVISION WAS PERFORMED ON (B)(6)2018. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NX011Z (PS FEMUR CEMENTED F5N LT), NX053Z (PS TIBIA CEMENTED T2), NX043 (UNIVERSAL PATELLA P3), NN261Z (TIBIAL OBTURATOR D12MM, L7MM). THE CEMENT USED WAS UNSPECIFIED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00471, 2916714-2020-00472, 2916714-2020-00474.

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

  MAUDE report 10684344 ↗
• InjurySep 29, 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. AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED KNEE PAIN, DIFFICULTY WALKING AND LOOSENING OF THE IMPLANT. 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 / MALFUNCTION IS FILED UNDER REFERENCE XC (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00378, 2916714-2020-00379, 2916714-2020-00380, 2916714-2020-00381. INVOLVED COMPONENTS: NX033Z (PS FEMUR CEMENTED F6N RT), NX057Z (PS TIBIA CEMENTED T4), NN264Z (TIBIAL OBTURATOR D14MM, L7MM), NX140 (PS PE INSERT T4/T4+, 10MM), NX043 (UNIVERSAL PATELLA P3). CEMENT: ZIMMER PALACOS R+G RADIOPAQUE BONE CEMENT(00-1113-140-01).

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 10601345 ↗