AS VEGA System® PS NX053ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 04046963810412), received between Oct 6, 2020 and May 1, 2026 — classified as 22 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Patient-Device Incompatibility

  A LAW FIRM REPORTS THAT A PATIENT ALLEGES POST-OPERATIVE LOOSENING OF AESCULAP KNEE IMPLANT. REPORTEDLY THERE WAS ALLEGED PAIN AND SWELLING 1 YEAR, 5 MONTHS POST OPERATIVE AFTER THE REVISION OF THE LEFT KNEE. THE ADVERSE EVENT IS FILED UNDER AIS REFERENCE: (B)(4).

  Patient problems: Implant Pain

  MAUDE report 25055810 ↗
• InjuryApr 27, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ONGOING ISSUES FOLLOWING A LEFT KNEE PROSTHESIS. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6) 2020 FOR DEGENERATIVE JOINT DISEASE. THE PROCEDURE WAS COMPLETED WITHOUT INTRAOPERATIVE COMPLICATIONS. POSTOPERATIVELY, THE PATIENT REPORTED PERSISTENT LEFT KNEE PAIN DESPITE CONSERVATIVE MANAGEMENT, INCLUDING PHYSICAL THERAPY AND CORTICOSTEROID INJECTIONS. CLINICAL NOTES DOCUMENT CONTINUED PAIN IN MULTIPLE REGIONS OF THE KNEE. BONE SCAN IMAGING LATER DEMONSTRATED INCREASED ACTIVITY AT THE TIP OF THE LEFT TIBIAL STEM WITH ASSOCIATED PAIN, NOTED AS POSSIBLY REPRESENTING LOOSENING OR PHYSIOLOGIC CHANGE. AT FOLLOW-UP ON (B)(6) 2026, IMAGING DEMONSTRATED A LEFT TOTAL KNEE PROSTHESIS IN PLACE WITH LUCENCY AT THE FEMORAL COMPONENT (POSTERIOR CUT) AND THE FEMORAL COMPONENT APPEARING LOOSE. CLINICAL FINDINGS INCLUDED PAIN AND SUPRAPATELLAR CLUNK, WITH DIAGNOSES OF MECHANICAL LOOSENING AND INSTABILITY OF THE LEFT KNEE PROSTHETIC JOINT. NO REVISION SURGERY OR INFECTION WAS DOCUMENTED IN THE AVAILABLE RECORDS. THIS REPORT IS FILED UNDER AIS REFERENCE: (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 24998404 ↗
• InjuryApr 27, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ONGOING ISSUES FOLLOWING A RIGHT KNEE PROSTHESIS. ACCORDING TO THE OPERATIVE REPORT, A PATIENT WITH A HISTORY OF BILATERAL KNEE DEGENERATIVE JOINT DISEASE AND PRIOR TOTAL KNEE ARTHROPLASTIES PRESENTED WITH ONGOING MUSCULOSKELETAL COMPLAINTS. THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6) 2016 WITHOUT INTRAOPERATIVE COMPLICATIONS. SUBSEQUENTLY, AFTER A MOTOR VEHICLE ACCIDENT IN (B)(6) 2022, THE PATIENT REPORTED NECK, BACK, HIP, AND LEFT KNEE PAIN. IMAGING AT THAT TIME DEMONSTRATED A LEFT TOTAL KNEE PROSTHESIS IN PLACE WITH NORMAL ALIGNMENT AND NO EVIDENCE OF LOOSENING OR INSTABILITY. THE PATIENT CONTINUED TO REPORT LEFT LOWER EXTREMITY PAIN WITH RADICULAR SYMPTOMS. AT A LATER FOLLOW-UP ON (B)(6) 2025, THE PATIENT PRESENTED WITH RIGHT KNEE PAIN AND LAXITY. IMAGING FINDINGS SUGGESTED LOOSENING OF THE RIGHT KNEE PROSTHESIS WITH SUSPECTED COMPONENT FAILURE, AND ADDITIONAL IMAGING WAS PLANNED FOR FURTHER EVALUATION. A CLINIC NOTE DATED (B)(6) 2026 DOCUMENTED PERSISTENT RIGHT KNEE PAIN THAT HAD NOT IMPROVED WITH INJECTIONS OR PHYSICAL THERAPY. THE EVENT IS FILED UNDER AIS REFERENCE (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 24997872 ↗
• 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 DECEMBER 15, 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 DECEMBER 27, 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 PRO

  Patient problems: Failure of Implant

  MAUDE report 24661556 ↗
• InjuryMar 11, 2026Patient-Device Incompatibility

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

  Patient problems: Failure of Implant

  MAUDE report 24570633 ↗
• InjuryMar 11, 2026Patient-Device Incompatibility

  The patient underwent revision left total knee arthroplasty on (b)(6) 2025 due to a loose total knee arthroplasty with gross instability.During revision surgery, the surgeon documented gross loosening of both the femoral and tibial components of the implanted Aesculap Vega knee system. The surgeon noted that the cement had completely debonded from both the femoral and tibial implants. The debonding was so pronounced that the implant imprints remained visible in the intact cement mantle following implant removal.The surgeon reported that the femoral component was grossly loose and could be removed with a periosteal elevator. The tibial component was also grossly loose and was easily removed with a periosteal elevator. The patellar button was additionally found to be loose and was removed. The event required revision total knee arthroplasty involving femoral and tibial component revision and patellar button removal. No intraoperative complications were reported. Patient was transferred to PACU in stable condition following revision surgery.The adverse event is filed under AIS reference (b)(4).

  Patient problems: Failure of Implant

  MAUDE report 24568884 ↗
• InjuryJun 16, 2025Loosening 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 COMPONENT OF COLUMBUS KNEE SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION, THIS KNEE IMPLANT WAS "DEFECTIVE AND FAILED PREMATURELY BECAUSE THE CERAMIC COATED SURFACE FAILS TO PROPERLY ADHERE TO THE CEMENT". THERE WAS POSTOPERATIVE MECHANICAL LOOSENING. IT WAS NOTED THAT THE SURGEON EASILY REMOVED THE IMPLANT BY HAND DURING THE REVISION. ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 22210710 ↗
• InjuryFeb 19, 2024Loosening 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 TIBIAL PLATEAU CEMENTED T2 (PART # NX053Z) WAS IMPLANTED DURING A PROCEDURE ON (B)(6) 2016. ACCORDING TO THE COMPLAINT THERE WAS A POSTOPERATIVE LOOSENING OF THE IMPLANT AT THE FEMORAL COMPONANT. X RAYS SHOW THAT THE CEMENT DID NOT ADHERE TO THE IMPLANTS OR THE BONE. REPORTEDLY THE PAITENT COMPLAINED OF RIGHT KNEE PAIN AFTER THE INITIAL PROCEDURE. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2024 WITH THE ITEM AN LOT INFORMATION. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). (B)(4) (2916714-2023-00092) NN261Z. (B)(4) (2916714-2023-00093) NX029Z. (B)(4) (2916714-2023-00094) NX042. (B)(4) (2916714-2024-00008) NX121.

  Patient problems: Failure of Implant

  MAUDE report 18735608 ↗
• InjuryOct 5, 2022Loosening 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 TIBIAL PLATEAU CEMENTED T2 (PART # NX053Z) WAS IMPLANTED DURING A PRIMARY PROCEDURE PERFORMED IN 2018. ACCORDING TO THE COMPLAINANT, THERE WAS POSTOPERATIVE LOOSENING OF THE IMPLANT. THIS OCCURRED DUE TO A PATIENT FALL. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVISION WAS REQUIRED; COLUMBUS REVISION PRODUCTS WERE IMPLANTED. FURTHER DETAILS HAVE BEEN REQUESTED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORT: (B)(4) (2916714-2022-00100) NX029Z.

  Patient problems: Bone Fracture(s)

  MAUDE report 15546502 ↗
• InjuryOct 4, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AECULAP AG THAT AN AS VEGA PS TIBIAL PLATEAU CEMENTED T2 (PART # NX053Z) WAS IMPLANTED DURING A PRIMARY PROCEDURE PERFORMED IN 2018. ACCORDING TO THE COMPLAINANT, THERE WAS POSTOPERATIVE LOOSENING OF THE IMPLANT. THIS OCCURRED DUE TO A PATIENT FALL. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVISION WAS REQUIRED; COLUMBUS REVISION PRODUCTS WERE IMPLANTED. FURTHER DETAILS HAVE BEEN REQUESTED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORT: (B)(4) (9610612-2022-00280) NX029Z.

  Patient problems: Failure of Implant

  MAUDE report 15539928 ↗
• 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, 2916714-2020-00386, 2916714-2020-00387, 2916714-2020-00388.

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

  MAUDE report 11640870 ↗
• InjuryMar 8, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NX053Z - AS VEGA PS TIBIAL PLATEAU CEMENTED T2. IT WAS REPORTED ON (B)(6) 2018. THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN AND DIFFICULTY WALKING WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2014, 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 AAG REFERENCE (B)(4). INVOLVED COMPONENTS: NN260P (PEEK PLUG F/ TIBIA), NX042 (UNIVERSAL PATELLA P2), NX031Z (PS FEMUR CEMENTED F5N RT), NX121 (PS PE INSERT T2/T2+, 12MM).

  Patient problems: Ambulation or Postural Difficulties; Implant Pain

  MAUDE report 11440420 ↗
• 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)(6) 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 (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: 2916714-2020-00319, 2916714-2020-00321, 2916714-2020-00322, 2916714-2020-00323.

  Patient problems: Ambulation or Postural Difficulties; Implant Pain

  MAUDE report 11440184 ↗
• 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)(4) 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: 2916714-2020-00325 2916714-2020-00326 2916714-2020-00327 2916714-2020-00328

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

  MAUDE report 11436242 ↗
• 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, 2916714-2020-00351, 2916714-2020-00352, 2916714-2020-00353.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11348483 ↗
• InjuryFeb 18, 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 NX053Z - AS VEGA PS TIBIAL PLATEAU CEMENTED T2. 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 IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: NX031Z (PS FEMUR CEMENTED F5N RT), NN260P (PEEK PLUG F/ TIBIA), NX043 (UNIVERSAL PATELLA P3), NX123 (PS PE INSERT T2/T2+, 16MM).

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 11345277 ↗
• 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, 2916714-2020-00658, 2916714-2020-00659.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 11210634 ↗
• 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, 2916714-2020-00640, 2916714-2020-00642, 2916714-2020-00643.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11118252 ↗
• 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 (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, 2916714-2020-00663, 2916714-2020-00664.

  Patient problems: Joint Laxity; Numbness; Pain

  MAUDE report 11113398 ↗
• 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, 2916714-2020-00653, 2916714-2020-00654.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 11058181 ↗
• 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) (REF. ASSOCIATED MDR ID 2916714-2020-00536), 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), 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 (B)(4). INVOLVED COMPONENTS: NX011Z - VEGA SYSTEM PS

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 10803659 ↗
• 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 XC (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00406, 2916714-2020-00407, 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 10635832 ↗