BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIV 2-HOLE SHL 48MM LNR SZ 22

    MDR report key: 7032726 · Received November 15, 2017

    Report

    Report Number
    0001825034-2017-10216
    Event Type
    Injury
    Date Received
    November 15, 2017
    Date of Event
    October 16, 2017
    Report Date
    November 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK092130
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. INSPECTION OF THE RETURNED DEVICE REVEALED THE LINER WAS RETURNED DISASSEMBLED WITH THE SHELL AND LOCKING RING. VISUAL INSPECTION OF THE LINER IDENTIFIED A GOUGE AND SEVERAL SMALL PITS ON THE OUTER RADIUS OF THE LINER. A PORTION OF THE LOCKING FEATURE OF THE LINER HAS BEEN ROUGHENED AND SLIGHTLY FLARED, WHICH INDICATED THE LOCKING RING HAD LOCKED THE LINER AND GOT DISASSEMBLED. ALL SCALLOPS WERE HEAVILY GOUGED AND DEFORMED AND A SCREW HOLE HAS BEEN DRILLED INTO THE INNER RADIUS OF THE LINER. NO DIMENSIONAL ANALYSIS WAS PERFORMED DUE TO THE DAMAGE TO THE LINER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT UNDERWENT BILATERAL HIP ARTHROPLASTY; AT THIS TIME, THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT COULD BE: 243260 OR 986240. (B)(4).CONCOMITANT PRODUCTS: 11-105902, ARCOM 28MM RNGLOC LNR HWALL 22, UNKNOWN. REPORT SOURCE, FOREIGN ¿ EVENTS OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 10215.

    Description of Event or Problem · 1

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LINER WOULD NOT SEAT PROPERLY, AND THE SURGEON WAS UNABLE TO REMOVE IT FROM THE CUP. THEREFORE, BOTH THE CUP AND THE LINER HAD TO BE REMOVED. THE PROCEDURE WAS DELAYED FOR 60 MINUTES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814285 UNIV 2-HOLE SHL 48MM LNR SZ 22 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 684210

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R