AS VEGA System® PS NX011ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04046963809904), received between Oct 6, 2020 and Jun 5, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ONGOING COMPLICATIONS ASSOCIATED WITH A VEGA KNEE IMPLANT. A REVISION SURGERY HAS NOT YET BEEN SCHEDULED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED. THIS REPORT IS FOR THE LEFT KNEE. THIS REPORT IS FILED UNDER AIS REFERENCE (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 25414762 ↗
• InjuryApr 22, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED COMPLICATIONS ASSOCIATED WITH A LEFT TOTAL KNEE REPLACEMENT (TKR). ACCORDING TO CLINICAL DOCUMENTATION, THE PATIENT INITIALLY UNDERWENT A LEFT TOTAL KNEE REPLACEMENT ON (B)(6) 2022. FOLLOWING THE TOTAL KNEE REPLACEMENT, THE PATIENT EXPERIENCED PERSISTENT SYMPTOMS, INCLUDING PAIN, INSTABILITY, RECURRENT BUCKLING, AND LIMITED FUNCTION OF THE LEFT KNEE. AN OFFICE VISIT DATED (B)(6) 2023 DOCUMENTED 3+ EFFUSION AND LATERAL LAXITY, WITH CONCERN FOR INSTABILITY. DUE TO ONGOING SYMPTOMS, THE PATIENT UNDERWENT REVISION LEFT KNEE ARTHROPLASTY ON (B)(6) 2023. OPERATIVE FINDINGS INCLUDED LOOSENING OF THE TIBIAL COMPONENT WITH OBSERVED MICROMOTION. THE PROCEDURE INVOLVED REMOVAL OF THE LOOSENED COMPONENT AND IMPLANTATION OF A REVISED TIBIAL COMPONENT WITH POLYETHYLENE INSERT. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. THIS REPORT IS FILED UNDER AIS REFERENCE (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 24954874 ↗
• InjuryMar 23, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ISSUES FOLLOWING A LEFT KNEE PROSTHESIS THAT REQUIRED SUBSEQUENT MEDICAL INTERVENTION. ACCORDING TO THE OPERATIVE REPORT DATED (B)(6) 2022, A PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY FOR OSTEOARTHRITIS. THE PROCEDURE WAS PERFORMED USING CEMENTED KNEE COMPONENTS (AESCULAP SYSTEM) WITH PALACOS BONE CEMENT. THE OPERATIVE REPORT INDICATES THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO INTRAOPERATIVE COMPLICATIONS, AND THE IMPLANTS WERE PLACED WITH APPROPRIATE ALIGNMENT AND STABILITY. ACCORDING TO A SUBSEQUENT OPERATIVE REPORT DATED (B)(6) 2023, THE PATIENT UNDERWENT A REVISION LEFT TOTAL KNEE ARTHROPLASTY DUE TO ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. INTRAOPERATIVELY, BOTH COMPONENTS WERE NOTED TO BE GROSSLY LOOSE, WITH NO CEMENT ADHERENT TO THE IMPLANTS. THE COMPONENTS WERE REMOVED WITHOUT SIGNIFICANT BONE LOSS. REVISION WAS PERFORMED USING STEMMED FEMORAL AND TIBIAL COMPONENTS, BONE CEMENT, AND ADJUNCTIVE MATERIALS INCLUDING ANTIBIOTIC BEADS. FINAL IMPLANTATION DEMONSTRATED STABLE FIXATION WITH APPROPRIATE ALIGNMENT AND FULL RANGE OF MOTION WITHOUT INSTABILITY. THE PATIENT TOLERATED THE PROCEDURE AND W

  Patient problems: Failure of Implant

  MAUDE report 24661555 ↗
• InjuryMar 20, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED POST-OPERATIVE LOOSENING FOLLOWING A LEFT KNEE ARTHROPLASTY PROCEDURE THAT REQUIRED SUBSEQUENT MEDICAL INTERVENTION. ACCORDING TO THE OPERATIVE REPORT DATED JULY 30, 2018, THE PATIENT UNDERWENT A PRIMARY LEFT TOTAL KNEE ARTHROPLASTY FOR DEGENERATIVE JOINT DISEASE (DJD). THE PROCEDURE WAS PERFORMED USING CEMENTED COMPONENTS, AND THE OPERATIVE REPORT INDICATES THAT THE IMPLANTS WERE PLACED WITH APPROPRIATE ALIGNMENT AND STABILITY. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. ACCORDING TO A SUBSEQUENT OPERATIVE REPORT DATED (B)(6) 2025, THE PATIENT UNDERWENT A REVISION LEFT TOTAL KNEE ARTHROPLASTY DUE TO FAILED PRIOR KNEE PROSTHESIS WITH LOOSENING OF COMPONENTS. INTRAOPERATIVELY, THE TIBIAL AND FEMORAL COMPONENTS WERE NOTED TO BE LOOSE AND WERE REMOVED WITHOUT DIFFICULTY. REVISION COMPONENTS WERE IMPLANTED USING BONE CEMENT, AND TRIALING DEMONSTRATED STABILITY THROUGH RANGE OF MOTION WITHOUT VARUS OR VALGUS LAXITY. THE OPERATIVE REPORT INDICATES THAT THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION AND NO INTRAOPERATIVE COMPLICATI

  Patient problems: Failure of Implant

  MAUDE report 24649241 ↗
• InjuryMar 19, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ISSUES FOLLOWING A LEFT KNEE PROSTHESIS THAT REQUIRED SUBSEQUENT MEDICAL INTERVENTION. ACCORDING TO THE OPERATIVE REPORT DATED (B)(6) 2021, THE PATIENT UNDERWENT A PRIMARY LEFT TOTAL KNEE ARTHROPLASTY FOR TRICOMPARTMENTAL DEGENERATIVE JOINT DISEASE (DJD) WITH MARKED TIBIAL TORSION. THE PROCEDURE WAS PERFORMED USING AESCULAP COMPONENTS, WHICH WERE CEMENTED IN PLACE USING PALACOS BONE CEMENT. THE OPERATIVE REPORT INDICATES THAT THE COMPONENTS WERE IMPLANTED WITH APPROPRIATE ALIGNMENT AND STABILITY, AND THE PATIENT WAS TAKEN TO RECOVERY IN GOOD CONDITION. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. ACCORDING TO A SUBSEQUENT OPERATIVE REPORT DATED (B)(6) 2023, THE PATIENT UNDERWENT LEFT KNEE MANIPULATION UNDER ANESTHESIA DUE TO POSTOPERATIVE ADHESIVE CAPSULITIS. THE PROCEDURE INVOLVED MANIPULATION OF THE KNEE FROM FULL EXTENSION TO APPROXIMATELY 125 DEGREES OF FLEXION. NO AUDIBLE OR PALPABLE ABNORMALITIES WERE NOTED, AND NO STRUCTURAL CHANGES TO THE KNEE WERE IDENTIFIED DURING THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO RECOVERY IN GOOD CONDITION. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 24639438 ↗
• InjuryMar 11, 2026Patient-Device Incompatibility

  ACCORDING TO THE EVENT DESCRIPTION: PATIENT REPORTS ALLEGED POST-OPERATIVE LOOSENING OF AESCULAP KNEE IMPLANT.

  Patient problems: Failure of Implant

  MAUDE report 24570630 ↗
• InjurySep 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  UPDATE: THERE HAD BEEN POSTOPERATIVE STIFFNESS IN 2022. ON (B)(6) 2023, REPLACEMENT OF THE GLIDING SURFACE IN THE LEFT KNEE WAS PERFORMED.

  Patient problems: Failure of Implant

  MAUDE report 23003377 ↗
• InjuryMar 25, 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 AN AESCULAP PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED KNEE PAIN AND LOOSENING OF THE IMPLANT. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2015, WHICH INCLUDED NON-AESCULAP IMPLANTS. A REVISION TO REPLACE NON-AESCULAP PRODUCTS WITH AESCULAP IMPLANTS OCCURRED ON (B)(6) 2017, AND THERE WAS NO REPORTED SECOND 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), NX059Z (PS TIBIA CEMENTED T5), NX152 (PS PE INSERT T5, 14MM), NN264Z (TIBIAL OBTURATOR D14MM, L7MM). ASSOCIATED MEDWATCHES: 2916714-2020-00397, 2916714-2020-00398, 2916714-2020-00399.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 11568267 ↗
• 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 NX011Z-AS VEGA PS FEMORAL COMP.CEMENTED F5N 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 BOTH KNEES, AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO THIS PAIN. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERIES 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. CEMENT USED: PALACOS R RADIOPAQUE BONE CEMENT. INVOLVED COMPONENTS: NX042 (UNIVERSAL PATELLA P2), NX112 (PS PE INSERT T1/T1+, 14MM), NN260P (PEEK PLUG F/ TIBIA). THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORT: 9610612-2020-00559 (NX051Z 400485940). THE SAME PATIENT HAS AN ADVERSE EVENT / MALFUNCTION FILED UNDER REFERENCE XC (B)(4) ( RIGHT KNEE).

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

  MAUDE report 11165849 ↗
• 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: 2916714-2020-00250, 2916714-2020-00251, 2916714-2020-00252, 2916714-2020-00253.

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

  MAUDE report 11013630 ↗
• InjuryNov 6, 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 LEFT (PART #NX011Z), VEGA SYSTEM TIBIA OBTURATOR 12MM T1-T3+ (PART # NN261Z) (REF. ASSOCIATED MDR ID 2916714-2020-00537), A VEGA SYSTEM PS TIBIA PLATEAU T2, CEMENTED IMPLANT (PART # NX053Z) (REF. ASSOCIATED MDR ID 2916714-2020-00538), AND A VEGA SYSTEM PS+ GLIDING SURFACE IMPLANT 10MM T2/T2+ (PART # NX220) (REF. ASSOCIATED MDR ID 2916714-2020-00539), WAS IMPLANTED DURING A PRIMARY SURGERY PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED KNEE PAIN, SWELLING, DIFFICULTY WALKING, AND LOOSENING & INSTABILITY OF THE IMPLANT, WHICH RESULTED IN A REVISION SURGERY BEING PERFORMED ON (B)(6) 2018. 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 INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE XC (B)(4). INVOLVED COMPONENTS: NX011Z - VEGA SYSTEM

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 10803594 ↗
• 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 PRODUCTS IMPLANTED, THE PATIENT HAS EXPERIENCED BILATERAL KNEE PAIN AND SWELLING; 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) 2018. INTRAOPERATIVE FINDINGS SHOWED LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. 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), NX042 (UNIVERSAL PATELLA P2), NX051Z (PS TIBIA CEMENTED T1), NX112 (PS PE INSERT T1/T1+, 14MM), NN260P (PEEK PLUG F/ TIBIA). THE CEMENT USED WAS PALACOS R RADIOPAQUE BONE CEMENT. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00546, 2916714-2020-00547, 2916714-2020-00548, 2916714-2020-00549. THE SAME PATIENT HAS AN ADVERSE EVENT / MALFUNCTION FILED UNDER REFERENCE (B)(4) (RIGHT KNEE).

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

  MAUDE report 10803369 ↗
• 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, SWELLLING, 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: 2916714-2020-00472. 2916714-2020-00473. 2916714-2020-00474.

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

  MAUDE report 10684345 ↗
• 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, SWELLING, 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: 2916714-2020-00417, 2916714-2020-00418, 2916714-2020-00419, 2916714-2020-00421.

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

  MAUDE report 10680329 ↗
• InjuryOct 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 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. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013 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: NX054Z (PS TIBIA CEMENTED T2+). NX044 (UNIVERSAL PATELLA P4). NX120 (PS PE INSERT T2/T2+, 10MM). NX011Z(PS FEMUR CEMENTED F5N LT). NN260P (PEEK PLUG F/TIBIA). ASSOCIATED MEDWATCHES: 2916714-2020-00460. 2916714-2020-00461. 2916714-2020-00462. 2916714-2020-00464.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 10652808 ↗
• InjuryOct 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. 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) 2012 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: 2916714-2020-00407, 2916714-2020-00408, 2916714-2020-00409, 2916714-2020-00410. INVOLVED COMPONENTS: NX011Z (PS FEMUR CEMENTED F5N LT), NN260P (PEEK PLUG F/ TIBIA), NX053Z (PS TIBIA CEMENTED T2), NX044 (UNIVERSAL PATELLA P4), NX120 (PS PE INSERT T2/T2+, 10MM). THE CEMENT USED IS UNIDENTIFIED.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 10635830 ↗