BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIV 2-HOLE SHL 52MM LNR SZ 23

    MDR report key: 7273081 · Received February 15, 2018

    Report

    Report Number
    0001825034-2018-01000
    Event Type
    Injury
    Date Received
    February 15, 2018
    Date of Event
    May 30, 2017
    Report Date
    March 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORT(S): 0001825034 - 2017 - 04554. CONCOMITANT MEDICAL PRODUCTS: PART # EP-108223 E-POLY 36MM +3 MAXROM LNR SZ23 LOT # 902590, PART # 15-103203 TAPERLOC MICROP LAT FMRL 9.0MM LOT # 016980, PART # 11-363660 36MM COCR MOD HD -6MM LOT # 532610. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PICTURES. THE PHOTOGRAPHS PROVIDED REVEALS RIM OF THE LINER EXHIBITS FRACTURE AND BLACK SOFT TISSUES. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. MULTIPLE REPORTS HAVE BEEN SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-04554-2, 0001825034-2018-01000-1.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WAS REVISED APPROXIMATELY 7 YEARS POST-IMPLANTATION DUE TO LINER BREAKAGE AND PAIN. THE LOCKING RING WAS UNABLE TO BE REMOVED DUE TO THE LINER BREAK, SO THE CUP WAS ALSO REMOVED AND REPLACED. 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
    118464 UNIV 2-HOLE SHL 52MM LNR SZ 23 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 865910

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R