BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIHAPRO SHELL HA/PC D52 W/PLGS

    MDR report key: 8825880 · Received July 25, 2019

    Report

    Report Number
    3002806535-2019-00625
    Event Type
    Injury
    Date Received
    July 25, 2019
    Report Date
    August 29, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Description of Event or Problem · 0

    PREMATURE LOOSENING OF HIP PROSTHESIS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENTS NOTICE AND THE ALLEGATIONS THERE IN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: COCR HD XL NK 32 +8MM 12/14, PART# P0206E32 AND LOT# 00J3235769; ARCOM 28MM RNGLOC LNR HWALL 23 WITH PART# 11-105903 AND LOT# 3220734; TAPERLOC BMPC 12.5X145MM 12/14 WITH PART# 650-0555BM AND LOT# 3249776. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00626, 3002806535-2019- 00627, 3006946279-2019-00335. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PREMATURE LOOSENING OF HIP PROSTHESIS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENTS NOTICE AND THE ALLEGATIONS THERE IN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620023 BIHAPRO SHELL HA/PC D52 W/PLGS HIP PROSTHESIS JDI BIOMET UK LTD. N/A 3360941

    Patients

    Seq Age Sex Outcome Treatment
    1 Other