AS VEGA System® PS NX009ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04046963809867), received between Apr 4, 2018 and Jun 8, 2026 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (14 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 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 (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 25431195 ↗
• InjuryMar 31, 2026Patient-Device Incompatibility

  AN ADVERSE EVENT WAS REPORTED INVOLVING AN UNKNOWN AESCULAP AG KNEE IMPLANT SYSTEM. SPECIFICALLY, AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED POSTOPERATIVE LOOSENING. PATIENT UNDERWENT A REVISION SURGERY. ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 24746034 ↗
• InjuryJan 20, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT A AS VEGA PS FEMORAL COMP.CEMENTED F4N L (PART# NX009Z) WAS IMPLANTED DURING A LEFT TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS WAS OBSERVED. THE PATELLA WAS NOTED AS BEING IN GOOD POSITION WITH NO EVIDENCE OF LOOSENING. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021. 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 PROCEDURE. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT/MALFUNCTION IS FILED UNDER AIC REFERENCE XC 100032171 CC 400582833. ASSOCIATED MEDWATCH REPORTS: 400582830_2916714-2023-00011_MDR, 400582831_2916714-2023-00012_MDR, 400582832_2916714-2023-00013_MDR, 400582834_2916714-2023-00015_MDR.

  Patient problems: Failure of Implant

  MAUDE report 16216574 ↗
• InjuryJan 20, 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 (PART# NN260P) WAS IMPLANTED DURING A LEFT TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS WAS OBSERVED. THE PATELLA WAS NOTED AS BEING IN GOOD POSITION WITH NO EVIDENCE OF LOOSENING. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021. 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 PROCEDURE. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT/MALFUNCTION IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: 400582830_2916714-2023-00011_MDR; 400582832_2916714-2023-00013_MDR; 400582833_2916714-2023-00014_MDR; 400582834_2916714-2023-00015_MDR.

  Patient problems: Failure of Implant

  MAUDE report 16216570 ↗
• InjuryJan 20, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT AN AS VEGA PS FEMORAL COMP.CEMENTED F4N L (PART# NX009Z) WAS IMPLANTED DURING A LEFT TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS WAS OBSERVED. THE PATELLA WAS NOTED AS BEING IN GOOD POSITION WITH NO EVIDENCE OF LOOSENING. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021. 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 PROCEDURE. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT/MALFUNCTION IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: 400582831_2916714-2023-00012_MDR, 400582832_2916714-2023-00013_MDR, 400582833_2916714-2023-00014_MDR, 400582834_2916714-2023-00015_MDR.

  Patient problems: Failure of Implant

  MAUDE report 16216568 ↗
• InjuryJan 19, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP AG THAT AN AS VEGA PS FEMORAL COMP.CEMENTED F4N L (PART # NX009Z) WAS IMPLANTED DURING A LEFT TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS WAS OBSERVED. THE PATELLA WAS NOTED AS BEING IN GOOD POSITION WITH NO EVIDENCE OF LOOSENING. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: (B)(4) - NX009Z. (B)(4) (9610612-2022-00388) - NX051Z. INVOLVED COMPONENTS: ((B)(4)) - NN260P - PLUG F/TIBIAL PLATEAU - LOT 51959433. ((B)(4)) - NX009Z - AS VEGA PS FEMORAL COMP.CEMENTED F4N L - LOT 51944942. ((B)(4)) - NX112 - VEGA PS GLIDING SURFACE T1/1+ - LOT 51946472.

  Patient problems: Insufficient Information

  MAUDE report 16207436 ↗
• 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 (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: 2916714-2020-00385, 2916714-2020-00386, 2916714-2020-00387, 2916714-2020-00388.

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

  MAUDE report 11640769 ↗
• 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 11527499 ↗
• 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 (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, 2916714-2020-00424, 2916714-2020-00425, 2916714-2020-00426.

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

  MAUDE report 11387852 ↗
• InjuryJan 13, 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 NX009Z-AS VEGA PS FEMORAL COMP.CEMENTED F4N L. IT WAS REPORTED ON (B)(6) 2019, THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN AND SWELLING IN LEFT KNEE, AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO THIS PAIN. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY WERE A WELL-FIXED PATELLAR COMPONENT AND 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. CEMENT USED WAS ZIMMER PALACOS R RADIOPAQUE BONE CEMENT. INVOLVED COMPONENTS: NX042 (UNIVERSAL PATELLA P2), NX103 (PS PE INSERT T0/T0+, 16MM), NN260P (PEEK PLUG F/ TIBIA) . THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORT: 9610612-2020-00556 (NX009Z 400485778), 9610612-2020-00557 (NX049Z 400485780).

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

  MAUDE report 11164716 ↗
• InjuryJan 13, 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 NX009Z-VEGA PS FEMORAL COMP.CEMENTED F4N L IT WAS REPORTED ON 15FEB2019, THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN AND SWELLING IN LEFT KNEE, AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO THIS PAIN. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY WERE LOOSENING OF THE FEMORAL COMPONENT, METALLOSIS AND DEBRIS IN THE KNEE JOINT, REACTIVE SYNOVITIS 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. INVOLVED COMPONENTS: NX042 (UNIVERSAL PATELLA P2). NX049Z (PS TIBIA CEMENTED T0). NX100 (PS PE INSERT T0/T0+, 10MM). NN260P (PEEK PLUG F/ TIBIA). ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 11164297 ↗
• 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: 2916714-2020-00620, 2916714-2020-00621, 2916714-2020-00622, 2916714-2020-00623.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 11119725 ↗
• 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: 2916714-2020-00501, 2916714-2020-00502, 2916714-2020-00503, 2916714-2020-00504.

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

  MAUDE report 10804425 ↗
• 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 AS VEGA KNEE, LEFT SIDE. IT WAS REPORTED THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED KNEE PAIN AND SWELLLING; AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO THE PAIN. THE PRIMARY PROCEDURE OCCURRED ON (B)(6) 2013, AND THE REVISION WAS PERFORMED ON (B)(6) 2016. INTRAOPERATIVE FINDINGS SHOWED LOOSENING OF THE FEMORAL COMPONENT, METALLOSIS AND DEBRIS IN THE KNEE JOINT, AND REACTIVE SYNOVITIS. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NX009Z (PS FEMUR CEMENTED F4N LT). NX042 (UNIVERSAL PATELLA P2). NX049Z (PS TIBIA CEMENTED T0). NX100 (PS PE INSERT T0/T0+, 10MM). NN260P (PEEK PLUG F/ TIBIA). THE CEMENT USED WAS UNSPECIFIED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00507, 2916714-2020-00508, 2916714-2020-00509, 2916714-2020-00510.

  Patient problems: Ambulation or Postural Difficulties; Pain; Synovitis

  MAUDE report 10802536 ↗
• InjuryOct 14, 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, SWELLLING, DIFFICULTY WALKING, AND LOOSENING AND INSTABILITY OF THE DEVICE. THE PRIMARY PROCEDURE OCCURRED ON (B)(6) 2016, AND THERE WAS NO REVISION PERFORMED. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NX009Z (PS FEMUR CEMENTED F4N LT). NX210 (PS PE INSERT T1/T1+, 10MM). NX052Z (PS TIBIA CEMENTED T1+). NN261Z (TIBIAL OBTURATOR D12MM, L7MM). NX043 (UNIVERSAL PATELLA P3). THE CEMENT USED IS BIOMET COBALT HV BONE CEMENT (402282). THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00418, 2916714-2020-00419, 2916714-2020-00420, 2916714-2020-00421.

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

  MAUDE report 10680341 ↗
• 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, SWELLING, DIFFICULTY WALKING, AND LOOSENING AND INSTABILITY OF THE IMPLANT. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2015 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). ASSOCIATED MEDWATCHES: 2916714-2020-00412, 2916714-2020-00413, 2916714-2020-00414, 2916714-2020-00415. INVOLVED COMPONENTS: NX009Z (PS FEMUR CEMENTED F4N LT). NX100 (PS PE INSERT T0/T0+, 10MM). NX049Z (PS TIBIA CEMENTED T0). NN260P (PEEK PLUG F/ TIBIA). NX042 (UNIVERSAL PATELLA P2). THE CEMENT USED IS UNIDENTIFIED.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 10601807 ↗
• MalfunctionApr 4, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  COUNTRY OF COMPLAINT: USA. RECEIVED VIA MEDWATCH (MW5075186): EVENT DESCRIPTION: TIBIAL LOOSENING, TOTAL KNEE REPLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. FILE WILL BE UPDATED WHEN INFORMATION IS RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7395689 ↗