BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUTRAL POLY LINER 36MM SET

    MDR report key: 16794948 · Received April 24, 2023

    Report

    Report Number
    0002648920-2023-00080
    Event Type
    Malfunction
    Date Received
    April 24, 2023
    Date of Event
    January 17, 2023
    Report Date
    April 21, 2023
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    UDI-DI
    00889024123762
    PMA / PMN Number
    K972774
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 00620205422 - TM MODULAR CUP ¿ 64553146; 00625006525 ¿ BONE SCREW ¿ J7378276; 00771301500 ¿ M/L TAPER STEM ¿ 64960515; 00784802300 ¿ KINECTIV NECK ¿ 65595695; 00877503602 ¿ BIOLOX HEAD ¿ 3133374. VISUAL EXAMINATION OF THE RETURNED PRODUCT/PROVIDED PICTURES IDENTIFIED NICKS, GOUGES, SCRATCHES, DEFORMATION, AND RIM FRACTURE. POLAR BOSS IS DEFORMED FROM ATTEMPTED IMPLANT. OUTER SPHERICAL SURFACE SHOWS GOUGES. FRACTURE IS NOTED NEAR THE ANTI ROTATION SCALLOPS AND THE LOCK RING GROOVE. GOUGE DAMAGE IS NOTED ON THE DAMAGED RIM. NO OTHER DAMAGE WAS NOTED. THE LINER WAS SENT TO FRACTURE ANALYSIS. RESULTS: THE LINER WAS NOT CENTERED OR ALIGNED WITH THE CUP WHEN IT WAS IMPACTED, AND THE MISALIGNMENT DURING IMPACTION RESULTED IN THE FRACTURE. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A ROOT CAUSE FOR THIS EVENT CANNOT BE DETERMINED. EVENT WAS PREVIOUSLY REPORTED UNDER A DIFFERENT MFR NUMBER, SEE 0001822565-2023- 00339. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE LINER BROKE DURING IMPACTION. THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1684826 NEUTRAL POLY LINER 36MM SET PROSTHESIS, HIP JWH ZIMMER MANUFACTURING B.V. N/A 64970887 00889024123762

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown