AS VEGA System® PS NX031ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04046963810160), received between Apr 4, 2018 and Apr 27, 2026 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (12 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• 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 24997870 ↗
• InjuryMar 16, 2026Patient-Device Incompatibility

  ACCORDING TO THE COMPLAINANT, ON (B)(6) 2023, THE PATIENT UNDERWENT REVISION ARTHROPLASTY OF THE RIGHT KNEE DUE TO A FAILED UNICOMPARTMENTAL KNEE REPLACEMENT. DURING THE PROCEDURE, THE COMPONENTS WERE EXPOSED AND REMOVED, AND THE KNEE WAS CONVERTED TO A TOTAL KNEE ARTHROPLASTY. TRIAL COMPONENTS DEMONSTRATED APPROPRIATE ALIGNMENT AND STABILITY. THE FINAL COMPONENTS WERE IMPLANTED USING BONE CEMENT. THE WOUND WAS IRRIGATED AND CLOSED IN LAYERS, AND THE PATIENT WAS TRANSFERRED TO RECOVERY IN GOOD CONDITION WITH NO INTRAOPERATIVE COMPLICATIONS REPORTED. SUBSEQUENTLY, ON (B)(6) 2025, THE PATIENT UNDERWENT AN ADDITIONAL REVISION PROCEDURE OF THE RIGHT KNEE. DURING THE PROCEDURE, THE EXISTING COMPONENTS AND RESIDUAL CEMENT WERE REMOVED. THE FEMUR AND TIBIA WERE PREPARED, AND NEW COMPONENTS WERE IMPLANTED WITH BONE CEMENT. TRIALING DEMONSTRATED STABILITY THROUGH RANGE OF MOTION WITH NO VARUS OR VALGUS LAXITY AND APPROPRIATE PATELLAR TRACKING. THE WOUND WAS CLOSED AND THE PATIENT WAS TRANSFERRED TO RECOVERY IN GOOD CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 24604758 ↗
• InjuryMar 12, 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. A REVISION SURGERY HAD BEEN PLANNED. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE ADVERSE EVENT IS FILED UNDER AESCULAP INC. REFERENCE NO. (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 24583872 ↗
• InjuryMar 11, 2026Patient-Device Incompatibility

  ACCORDING TO THE COMPLAINANT, THERE WAS AN ISSUE WITH THE AESCULAP CERAMIC-COATED KNEE IMPLANT. REPORTEDLY, THE CERAMIC COATED SURFACE FAILED TO PROPERLY ADHERE TO THE CEMENT WHICH CAUSED THE IMPLANT TO FAIL PREMATURELY. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2025. THE PATIENT HAD COMPLAINED OF PAIN AND STIFFNESS OF THE RIGHT KNEE POSTOPERATIVELY. A REVISION WAS PERFORMED. IT WAS REPORTED THAT THE PATIENT WAS STILL OUT OF WORK AND ATTENDING PHYSICAL THERAPY.

  Patient problems: Failure of Implant

  MAUDE report 24574931 ↗
• InjuryMar 11, 2026Patient-Device Incompatibility

  ACCORDING TO THE COMPLAINANT, THERE WAS AN ISSUE WITH THE AESCULAP CERAMIC-COATED KNEE IMPLANT. REPORTEDLY, THE CERAMIC COATED SURFACE FAILED TO PROPERLY ADHERE TO THE CEMENT WHICH CAUSED THE IMPLANT TO FAIL PREMATURELY. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2025. THE PATIENT HAD COMPLAINED OF PAIN AND STIFFNESS OF THE RIGHT KNEE POSTOPERATIVELY. A REVISION WAS PERFORMED. IT WAS REPORTED THAT THE PATIENT WAS STILL OUT OF WORK AND ATTENDING PHYSICAL THERAPY.

  Patient problems: Failure of Implant

  MAUDE report 24568886 ↗
• InjuryMar 11, 2026Patient-Device Incompatibility

  ACCORDING TO THE COMPLAINANT, THERE WAS AN ISSUE WITH THE AESCULAP CERAMIC-COATED KNEE IMPLANT. REPORTEDLY, THE CERAMIC COATED SURFACE FAILED TO PROPERLY ADHERE TO THE CEMENT WHICH CAUSED THE IMPLANT TO FAIL PREMATURELY. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2025. THE PATIENT HAD COMPLAINED OF PAIN AND STIFFNESS OF THE RIGHT KNEE POSTOPERATIVELY. A REVISION WAS PERFORMED. IT WAS REPORTED THAT THE PATIENT WAS STILL OUT OF WORK AND ATTENDING PHYSICAL THERAPY.

  Patient problems: Failure of Implant

  MAUDE report 24568885 ↗
• InjuryJun 8, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00447 (400515522 + NX055Z). INVOLVED COMPONENTS (AUFFÜHREN IN D11 + C2). NX130 - VEGA PS GLIDING SURFACE T3/3+ 10MM - LOT 52564765.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 11959784 ↗
• 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 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: 2916714-2020-00319, 2916714-2020-00320, 2916714-2020-00321, 2916714-2020-00323.

  Patient problems: Ambulation or Postural Difficulties; Implant Pain

  MAUDE report 11440324 ↗
• 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, 2916714-2020-00326, 2916714-2020-00327, 2916714-2020-00328.

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

  MAUDE report 11436252 ↗
• 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: 2916714-2020-00350, 2916714-2020-00351, 2916714-2020-00352, 2916714-2020-00353.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11348428 ↗
• 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), 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) (REF. ASSOCIATED MDR ID 2916714-2020-00628), 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. ADDIT

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 11248032 ↗
• 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 A VEGA KNEE IMPLANT SYSTEM WAS IMPLANTED DURING A PRIMARY SURGERY OF THE RIGHT KNEE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED RIGHT KNEE PAIN, ALONG WITH LOOSENING AND INSTABILITY OF THE IMPLANT. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2016. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO KNOWN ADVERSE PATIENT EFFECTS OCCURRED AS A RESULT OF THE REVISION SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Implant Pain

  MAUDE report 11247662 ↗
• 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, 2916714-2020-00641, 2916714-2020-00642, 2916714-2020-00643.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11117932 ↗
• 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: 2916714-2020-00661, 2916714-2020-00662, 2916714-2020-00663, 2916714-2020-00664.

  Patient problems: Joint Laxity; Numbness; Pain

  MAUDE report 11113044 ↗
• 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: 2916714-2020-00632, 2916714-2020-00633, 2916714-2020-00634, 2916714-2020-00635.

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

  MAUDE report 10969765 ↗
• 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), 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) (REF. ASSOCIATED MDR ID 2916714-2020-00554), 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 INFO

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 10826158 ↗
• 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 (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00496, 2916714-2020-00497, 2916714-2020-00498, 2916714-2020-00499.

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

  MAUDE report 10816399 ↗
• 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), 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) (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. T

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 10815756 ↗
• 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: 2916714-2020-00517, 2916714-2020-00518, 2916714-2020-00519, 2916714-2020-00520.

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

  MAUDE report 10802779 ↗
• MalfunctionApr 4, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  COUNTRY OF COMPLAINT: USA RECEIVED VIA MEDWATCH (MW5075167): TIBIA LOOSENING FEMUR OF TOTAL KNEE, TOTALLY LOOSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. FILE WILL BE UPDATED WHEN INFORMATION IS RECEIVED. MED /WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 9610612-2018-00159.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7395706 ↗