AESCULAP NX042Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04046963810283), received between Sep 15, 2020 and Oct 6, 2023 — classified as 14 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 6, 2023Loosening 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 SYSTEM (PART # UNKNOWN) WAS IMPLANTED DURING A PROCEDURE ON (B)(6) 2016. ACCORDING TO THE COMPLAINT THERE WAS A POSTOPERATIVE LOOSENING OF THE IMPLANT. X RAYS SHOW THAT THE CEMENT DID NOT ADHERE TO THE IMPLANTS OR THE BONE. REPORTEDLY THE PATIENT COMPLAINED OF RIGHT KNEE PAIN AFTER THE INITIAL PROCEDURE. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). REFERENCE ASSOCIATED MEDWATCH REPORTS: (B)(4) (2916714-2023-00092) (B)(6). (B)(4) (2916714-2023-00093) (B)(6).

  Patient problems: Failure of Implant

  MAUDE report 17884973 ↗
• 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, 2916714-2020-00385, 2916714-2020-00386, 2916714-2020-00388.

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

  MAUDE report 11641008 ↗
• 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, 2916714-2020-00320, 2916714-2020-00322, 2916714-2020-00323.

  Patient problems: Ambulation or Postural Difficulties; Implant Pain

  MAUDE report 11440320 ↗
• InjuryFeb 25, 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) 2015. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED PAIN AND DIFFICULTY WALKING OF THE IMPLANT. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018. 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: NX007Z (PS FEMUR CEMENTED F3N LT); NN260P (PEEK PLUG F/ TIBIA); NX049Z (PS TIBIA CEMENTED T0); NX042 (UNIVERSAL PATELLA P2); NX102 (PS PE INSERT T0/T0+, 14MM). CEMENT USED IS UNKNOWN. ASSOCIATED MEDWATCHES: 2916714-2020-00312, 2916714-2020-00313, 2916714-2020-00314, 2916714-2020-00316.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 11381945 ↗
• 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: 2916714-2020-00619, 2916714-2020-00621, 2916714-2020-00622, 2916714-2020-00623.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 11120141 ↗
• 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) (REF. ASSOCIATED MDR ID 2916714-2020-00550), VEGA SYSTEM PATELLA 3-PEG SIZE P2 (PART # NX042), 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. THE ADVERSE EV

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 10826157 ↗
• 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 AS VEGA KNEE, RIGHT SIDE. IT WAS REPORTED THAT AS A RESULT OF HAVING THE PRODUCTS IMPLANTED, THE PATIENT HAS EXPERIENCED KNEE PAIN AND SWELLING; AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO THE PAIN. THE PRIMARY PROCEDURE OCCURRED ON (B)(6) 2012, AND THE REVISION WAS PERFORMED ON (B)(6) 2018. INTRAOPERATIVE FINDINGS WERE REACTIVE SYNOVITIS WITH AREAS OF NECROTIC TISSUE AND LOOSENING OF THE FEMORAL COMPONENT . ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NX027Z (PS FEMUR CEMENTED F3N RT), NX042 (UNIVERSAL PATELLA P2), NX049Z (PS TIBIA CEMENTED T0), NX102 (PS PE INSERT T0/T0+, 14MM), NN260P (PEEK PLUG F/ TIBIA). THE CEMENT USED WAS BIOMET COBALT HV BONE CEMENT. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00605, 2916714-2020-00607, 2916714-2020-00608, 2916714-2020-00609.

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

  MAUDE report 10809199 ↗
• 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: 2916714-2020-00500, 2916714-2020-00502, 2916714-2020-00503, 2916714-2020-00504.

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

  MAUDE report 10804501 ↗
• 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: 2916714-2020-00545, 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 10803431 ↗
• 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 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) 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: 2916714-2020-00506, 2916714-2020-00508, 2916714-2020-00509, 2916714-2020-00510.

  Patient problems: Ambulation or Postural Difficulties; Pain; Synovitis

  MAUDE report 10802522 ↗
• 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. IT WAS REPORTED THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED KNEE PAIN, DIFFICULTY WALKING, AND LOOSENING AND INSTABILITY OF THE DEVICE. THE PRIMARY PROCEDURE OCCURRED ON (B)(6) 2015, 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: NN261Z (TIBIAL OBTURATOR D12MM, L7MM). NX049Z (PS TIBIA CEMENTED T0). NX008Z (PS FEMUR CEMENTED F3 LT). NX042 (UNIVERSAL PATELLA P2). NX101 (PS PE INSERT T0/T0+, 12MM). THE CEMENT USED WAS UNSPECIFIED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00490, 2916714-2020-00491, 2916714-2020-00492, 2916714-2020-00494.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 10801747 ↗
• 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, LOOSENING, AND INSTABILITY OF THE IMPLANT. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2016, 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: (B)(4). INVOLVED COMPONENTS: NX042 (UNIVERSAL PATELLA P2); NX033Z(PS FEMUR CEMENTED F6N RT); NN264Z(TIBIAL OBTURATOR D14MM, L7MM); NX056Z(PS TIBIA CEMENTED T3+); NX130 (PS PE INSERT T3/T3+, 10MM). ASSOCIATED MEDWATCHES: 2916714-2020-00477; 2916714-2020-00478; 2916714-2020-00479; 2916714-2020-00480.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 10653156 ↗
• 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 XC (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00411, 2916714-2020-00412, 2916714-2020-00413, AND 2916714-2020-00414. 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 10601844 ↗
• InjurySep 15, 2020Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth

  NO UPDATES.

  Patient problems: Joint Laxity; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10535595 ↗