BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS TIBIA EXTENSION STEM 10X52MM CEMENTED

    MDR report key: 24454937 · Received February 26, 2026

    Report

    Report Number
    9610612-2026-00034
    Event Type
    Injury
    Date Received
    February 26, 2026
    Report Date
    March 9, 2026
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    PMA / PMN Number
    K101281
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A3 - GENDER, B5 - DESCRIPTION UPDATED, B6 - TEST DATA, B7 - MEDICAL HISTORY, D1&2 - BRAND NAME, COMMON DEVICE NAME, PRODUCT CODE, D4 - MATERIAL CODE, BATCH NUMBER, EXPIRATION DATE, D10 - INVOLVED COMPONENTS, G4 - 510K, H4 - EXPIRATION DATE.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    UPDATE: THE MATERIAL HAS BEEN UPDATED TO NX060Z - AS TIBIA EXTENSION STEM 10X52MM CEMENTED. THIS DEVICE IS NOW CONSIDERED TO BE AN INVOLVED COMPONENT. ON (B)(6) 2018 AND (B)(6) 2019 A RIGHT TOTAL KNEE ARTHROPLASTY (TKA) HAD BEEN PERFORMED. ON 30DEC2021 A LEFT TKA WAS PERFORMED. ASSOCIATED MEDWATCH REPORTS: NX011Z (AESCULAP AG REFERENCE (B)(4); 9610612-2026-00039), NX031Z (AESCULAP AG REFERENCE (B)(4); 9610612-2026-00054), NX053Z (AESCULAP AG REFERENCE (B)(4); 9610612-2026-00049). INVOLVED COMPONENTS: NX060Z/ AS TIBIA EXTENSION STEM 10X52MM CEMENTED (AESCULAP AG REFERENCE (B)(4): 9610612-2026-00034). UNKNOWN COMPONENT AESCULAP AG VEGAL KNEE SYSTEM IMPLANT (AESCULAP AG REFERENCE (B)(4)). NX062Z/ AS TIBIA EXTENSION STEM 12X52MM CEMENTED (AESCULAP AG REFERENCE (B)(4)). NX220/ VEGA PS+ GLIDING SURFACE T2/2+ 10MM (AESCULAP AG REFERENCE (B)(4)).

    Description of Event or Problem · 0

    AN ADVERSE EVENT WAS REPORTED INVOLVING AN UNKNOWN AESCULAP AG KNEE IMPLANT SYSTEM. SPECIFICALLY, IT WAS REPORTED THAT THERE WAS POSTOPERATIVE LOOSENING. A REVISION SURGERY HAD BEEN PLANNED. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, REVISION SURGERY. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341057 AS TIBIA EXTENSION STEM 10X52MM CEMENTED KNEE ENDOPROSTHETICS JWH AESCULAP AG NX060Z 52679492

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention NX060Z - LOT 52679492.| NX062Z - LOT 52457164.| NX220 - LOT 52462538.| UNKNOWN AESCULAP AG VEGA KNEE SYSTEM IMPLANT.