BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER AND SHELL WITH PLASTIC BARRIER 40 MM I.D. 50 MM O.D.

    MDR report key: 11445800 · Received March 9, 2021

    Report

    Report Number
    0001822565-2021-00624
    Event Type
    Injury
    Date Received
    March 9, 2021
    Date of Event
    March 2, 2021
    Report Date
    August 5, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MRA
    PMA / PMN Number
    EXPORT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE EVENT WAS CONFIRMED WITH MEDICAL RECORDS AND PRODUCT RECEIVED. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED A COATED SPHERICAL SURFACE SHELL WITH SOME BIO DEBRIS. INNER SPHERICAL SURFACE AND SHELL OUTER RIM SHOW NICKS, GOUGES, AND SCRATCHES FROM USE. NO ADDITIONAL EVALUATION CAN BE PERFORMED WITH THE PICTURES PROVIDED. REVIEW OF THE AVAILABLE MEDICAL RECORDS IDENTIFIED THE FOLLOWING: INITIAL RIGHT TOTAL HIP ARTHROPLASTY: NO INTRAOPERATIVE COMPLICATIONS WERE FOUND. PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF THE CUP, AND WAS FOUND THAT THERE WAS NO IMPINGEMENT, AND NO OSTEOINTEGRATION. ADDITIONALLY, THE STEM WAS WELL POSITIONED AND FULLY INGROWN. THE CUP AND HEAD WERE REPLACED WITHOUT COMPLICATION. DEVICE HISTORY RECORD 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG#: 00877704001 BIOLOX® OPTION, HEAD, S, ø 40/-3.0, TAPER 12/14 LOT#: 2952008. REPORT SOURCE: FOREIGN: (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 2 YEARS AND 6 MONTHS POST IMPLANTATION DUE TO LOOSENING AND PAIN. MAXERA WAS STILL IN THE GOOD POSITION, BUT NO INGROWTH AT ALL. CUP WAS ONLY STABLE BY PRESS FIT. BONE STOCK WAS PERFECT. NO RESIDUAL CARTILAGE. TRABECULAR BLEEDING BONE VISIBLE. 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
    342949 LINER AND SHELL WITH PLASTIC BARRIER 40 MM I.D. 50 MM O.D. PROSTHESIS, HIP MRA ZIMMER BIOMET, INC. N/A 63834865

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R