AS univation XFRecalls & reported problems across all models
Aesculap AG · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls
- 0
We found 14 models of AS univation XF by Aesculap AG in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Oct 9, 2020 and Mar 2, 2022 — classified as 23 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (18 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported AS univation XF problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth18
- Biocompatibility2
- Insufficient Device Problem Information2
- Detachment of Device or Device Component1
- Patient-Device Incompatibility1
Patient problems
- Failure of Implant15
- Ambulation or Postural Difficulties3
- Arthritis2
- Insufficient Information2
- Joint Laxity2
- Post Operative Wound Infection2
- Discomfort1
- Implant Pain1
AS univation XF models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AS univation® XF NO188ZPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- AS univation® XF NO165ZPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- AS univation® XF NO183ZPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- AS univation® XF NO187ZPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- AS univation® XF NO182ZPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- AS univation® XF NO184ZPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- AS univation® XF NO157ZPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- AS univation® XF NO159ZPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- AS univation® XF NO160ZPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- AS univation® XF NO161ZPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- AS univation® XF NO162ZPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- AS univation® XF NO163ZPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- AS univation® XF NO164ZPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- AS univation® XF NO166ZPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
Recent AS univation XF adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMar 2, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED TO AESCULAP AG THAT AN AS UNIVATION XF TIBIA CEMENTED T3 LM (PART # NO164Z) WAS IMPLANTED DURING A PRIMARY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, FOLLOWING IMPLANTATION, THE PATIENT EXPERIENCED PAIN. RADIOGRAPHIC AND SCINTIGRAPHIC EXAMINATION CONFIRMED LOOSENING OF IMPLANT. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022 WHICH REVEALED A COMPLETE LOOSENING, BOTH TIBIALLY AND FEMORALLY, IN THE PROSTHESIS/CEMENT INTERFACE. SO FAR, NO EVIDENCE OF INFECTION. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVISION SURGERY WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: ((B)(4) - NO164Z), 9610612-2022-00038 ((B)(4) - NO187Z). INVOLVED COMPONENTS: NL472 - UNIVATION F MENISCAL COMP.T3 RM/LM 7MM - LOT 52592618.
Patient problems: Failure of Implant
MAUDE report 13654593 ↗InjuryMar 2, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED TO AESCULAP AG THAT AN AS UNIVATION XF FEMUR CEMENTED F3 LM (PART # NO187Z) WAS IMPLANTED DURING A PRIMARY PROCEDURE PERFORMED ON OCTOBER 5, 2020. ACCORDING TO THE COMPLAINANT, FOLLOWING IMPLANTATION, THE PATIENT EXPERIENCED PAIN. RADIOGRAPHIC AND SCINTIGRAPHIC EXAMINATION CONFIRMED LOOSENING OF IMPLANT. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022 WHICH REVEALED A COMPLETE LOOSENING, BOTH TIBIALLY AND FEMORALLY, IN THE PROSTHESIS/CEMENT INTERFACE. SO FAR, NO EVIDENCE OF INFECTION. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVISION SURGERY WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE XC 100030121; CC 400544176. ASSOCIATED MEDWATCH-REPORTS: 9610612-2022-00037 (400544175 - NO164Z). 9610612-2022-00038 (400544176 - NO187Z). INVOLVED COMPONENTS: NL472 - UNIVATION F MENISCAL COMP.T3 RM/LM 7MM - LOT 52592618.
Patient problems: Failure of Implant
MAUDE report 13654561 ↗InjuryJul 8, 2021Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth; Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth
THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) , 2021. ADDITIONAL INVOLVED COMPONENT: NL470-UNIVATION F MENISCAL COMP.T1 RM/LM 7MM - LOT # 52502901
Patient problems: Discomfort; Implant Pain
MAUDE report 12134782 ↗InjuryMay 20, 2021Biocompatibility; Biocompatibility
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NO165Z - AS UNIVATION XF TIBIA CEMENTED T4 LM. ACCORDING TO THE COMPLAINT DESCRIPTION, THERE WAS A POSTOPERATIVE KNEE INFECTION. THE PATIENT REQUIRED A POLY SWAP. DURING THE REPLACEMENT PROCEDURE, IT WAS NOTED THAT THE "FEMUR FELL OFF". A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE ADVERSE EVENT IS FILED UNDER (B)(4). ASSOCIATED MEDWATCH REPORTS: 9610612-2021-00332 ((B)(4)+ NO188Z). INVOLVED COMPONET: NL473 -UNIVATION F MENISCAL COMP.T4 RM/LM 7MM - 52047925.
Patient problems: Failure of Implant
MAUDE report 11856559 ↗InjuryMay 18, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4) ((B)(4)).
Patient problems: Failure of Implant
MAUDE report 11845293 ↗InjuryMay 18, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: Failure of Implant
MAUDE report 11845292 ↗InjuryMay 5, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED TO AESCULAP AG THAT AS UNIVATION XF FEMUR CEMENTED F4 RM (PART # NO183Z) WAS IMPLANTED DURING A PRIMARY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, APPROXIMATELY 5 MONTHS AND 10 DAYS FOLLOWING THE PROCEDURE, THE IMPLANT LOOSENED. ASEPTIC EARLY LOOSENING OF THE MEDIAL KNEE HEMIPROSTHESIS ON THE RIGHT KNEE WAS REPORTED. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00348 (LOT # 52498758; NO160Z). INVOLVED COMPONENTS: NL480: UNIVATION F MENISCAL COMP.T5 RM/LM 8MM - LOT 52569651.
Patient problems: Failure of Implant
MAUDE report 11780507 ↗InjuryMay 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 NO160Z - AS UNIVATION XF TIBIA CEMENTED T5 RM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE IMPLANT LOOSENED 5 MONTH AND 10 DAYS POST SURGERY. ASEPTIC EARLY LOOSENING OF THE MEDIAL KNEE HEMIPROSTHESIS ON THE RIGHT. IMPLANTATION DATE: (B)(6) 2020. REVISION DATE: (B)(6) 2021. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00349 (400509551 + NO183Z), 9610612-2021-00348 (400509552 + NO160Z). INVOLVED COMPONENTS: NL480 - UNIVATION F MENISCAL COMP.T5 RM/LM 8MM - LOT 52569651.
Patient problems: Failure of Implant
MAUDE report 11769267 ↗InjuryApr 22, 2021Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AN AS UNIVATION XF FEMUR. ACCORDING TO THE COMPLAINT DESCRIPTION, THERE WAS A POSTOPERATIVE KNEE INFECTION. THE PATIENT REQUIRED A POLY -SWAP. DURING THE REPLACEMENT PROCEDURE, IT WAS NOTED THAT THE "FEMUR FELL OFF". A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: Post Operative Wound Infection
MAUDE report 11712113 ↗InjuryApr 22, 2021Biocompatibility; Biocompatibility
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NO188Z - AS UNIVATION XF FEMUR CEMENTED F4 LM. ACCORDING TO THE COMPLAINT DESCRIPTION, THERE WAS A POSTOPERATIVE KNEE INFECTION. THE PATIENT REQUIRED A POLY SWAP. DURING THE REPLACEMENT PROCEDURE, IT WAS NOTED THAT THE "FEMUR FELL OFF". A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: Failure of Implant; Post Operative Wound Infection
MAUDE report 11711665 ↗InjuryMar 31, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00235 (400505588 - NO183Z). 9610612-2021-00226 (400505587 - NO159Z). INVOLVED COMPONENTS NL473 - UNIVATION F MENISCAL COMP.T4 RM/LM 7MM - 52494281.
Patient problems: Failure of Implant
MAUDE report 11598682 ↗InjuryMar 31, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00235 (400505588 - NO183Z) 9610612-2021-00226 (400505587 - NO159Z) INVOLVED COMPONENTS NL473 - UNIVATION F MENISCAL COMP.T4 RM/LM 7MM - 52494281
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 11598600 ↗InjuryMar 7, 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 NO188Z-AS UNIVATION XF FEMUR CEMENTED F4 LM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE UNIVATION X NO188Z AND NO165Z IMPLANTS HAVE LOOSENED. NO CEMENT ADHESION CAN BE OBSERVED ON THE IMPLANTS. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00114 (400502135 NO188Z), 9610612-2021-00115 (400502136 NO165Z). INVOLVED COMPONENTS (AUFFÜHREN IN D11 + C2) NL479-UNIVATION F MENISCAL COMP.T4 RM/LM 8MM-52462745.
Patient problems: Failure of Implant
MAUDE report 11426347 ↗InjuryMar 7, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00114 ((B)(4) NO188Z); 9610612-2021-00115 ((B)(4) NO165Z). INVOLVED COMPONENTS (AUFFÜHREN IN D11 + C2). NL479-UNIVATION F MENISCAL COMP.T4 RM/LM 8MM-52462745.
Patient problems: Failure of Implant
MAUDE report 11426346 ↗InjuryJan 29, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00986 ((B)(4) NO165Z) INVOLVED COMPONENTS : NL473-UNIVATION F MENISCAL COMP.T4 RM/LM 7MM-51976008.
Patient problems: Failure of Implant
MAUDE report 11254365 ↗
Other Aesculap AG products
All Aesculap AG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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