BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A TPR HI CARBON 37/28MM LNR

    MDR report key: 11286337 · Received February 5, 2021

    Report

    Report Number
    0001825034-2021-00381
    Event Type
    Injury
    Date Received
    February 5, 2021
    Date of Event
    January 16, 2007
    Report Date
    June 16, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K993438
    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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS NOTING THE PATIENT EXPERIENCED A DISLOCATION AND UNDERWENT A CLOSED REDUCTION. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY. SCARRING WAS NOTED AT THE GLUTEUS MAXIMUS FASCIA. NONPURULENT FLUID ENCOUNTERED UPON OPENING THE PSEUDOCAPSULE. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE IS 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: 11-163677 ¿ M2A TAPER HEAD ¿ 738780; 15-103650 ¿ M2A TAPER SHELL ¿ 232620; 103534 ¿ TI LOW PROFILE SCREW ¿ 978660; 103534 ¿ TI LOW PROFILE SCREW - 978660; 103200 - TAPERLOC STEM ¿ 143910. CUSTOMER HAS INDICATED THAT PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS AND A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2021 - 00380.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 3 MONTHS POST IMPLANTATION DUE TO EXPERIENCING MULTIPLE DISLOCATIONS. DURING THE REVISION, SCARRING AND PSEUDOCAPSULE WERE NOTED. THE HEAD, LINER AND SHELL WERE REMOVED AND REPLACED WITH A CONSTRAINED SYSTEM WITHOUT COMPLICATIONS. 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
    182856 M2A TPR HI CARBON 37/28MM LNR PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 845960

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R