AS NN261ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04046963124502), received between Oct 15, 2020 and Jun 8, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (6 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 8 most recent of 8 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 25432405 ↗
• 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) (2916714-2023-00093) AE-QAS-K521-56, (B)(4) (2916714-2023-00094) AE-QAS-K521-56.

  Patient problems: Failure of Implant

  MAUDE report 17884975 ↗
• 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 11387807 ↗
• 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 11113141 ↗
• 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: 2916714-2020-00249, 2916714-2020-00250, 2916714-2020-00251, 2916714-2020-00252.

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

  MAUDE report 11015211 ↗
• 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), 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 10803602 ↗
• 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: 2916714-2020-00491. 2916714-2020-00492. 2916714-2020-00493. 2916714-2020-00494.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 10801739 ↗
• 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: 2916714-2020-00471. 2916714-2020-00472. 2916714-2020-00473.

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

  MAUDE report 10684339 ↗