BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP NON FLARED SZ 52MM

    MDR report key: 9941071 · Received April 8, 2020

    Report

    Report Number
    0001825034-2020-01560
    Event Type
    Injury
    Date Received
    April 8, 2020
    Date of Event
    February 25, 2020
    Report Date
    June 23, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. OPERATIVE NOTES WERE NOT PROVIDED. PATIENT RECORDS FROM THE STUDY WERE PROVIDED AND REVIEWED BY AN HCP. PATIENT UNDERWENT AN INITIAL RIGHT THA ON DUE TO OA. THERE WERE NO INTRAOPERATIVE COMPLICATIONS NOTED. PATIENT UNDERWENT A REVISION PROCEDURE DUE TO PSEUDOTUMORS AND INFECTION. AN XRAY WAS PROVIDED AND REVIEWED BY AN HCP. THE REVIEW CONCLUDED POSSIBLE FOCAL OSTEOPENIA INVOLVING THE GREATER TROCHANTER SUGGESTING OSTEOLYSIS AND A POSSIBLE FRACTURE INVOLVING THE LATERAL CORTEX OF THE PROXIMAL FEMORAL DIAPHYSIS. THE FIT AND ALIGNMENT OF THE IMPLANTS WAS NOTED AS APPROPRIATE. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITIVE ROOT CAUSE FOR THE PSEUDOTUMORS CANNOT BE DETERMINED. HOWEVER, AS THE REPORTED INFECTION OCCURRED GREATER THAN ONE YEAR FROM IMPLANTATION, THE PATIENT DID NOT SHOW SIGNS OR SYMPTOMS OF INFECTION WITHIN THE FIRST YEAR, AND THE DEVICE WAS STERILIZED PER SPECIFICATION, IT IS UNLIKELY THAT THE REPORTED INFECTION IS RELATED TO THE IMPLANTED ZIMMER BIOMET DEVICE. THE PRODUCT OPERATED WITHIN SPECIFICATION. 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). CATALOG NUMBER: 12-115130, LOT NUMBER: 1620263, BRAND NAME: CER BIOLOXD MOD HD 38MM; CATALOG NUMBER: 162032, LOT NUMBER: 1772937, BRAND NAME: BI-METRIC HAP 12X140 MM. REPORT SOURCE: (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PSEUDOTUMOR AND INFECTION APPROXIMATELY 10 YEARS POST IMPLANTATION. 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
    397330 M2A-38 CUP NON FLARED SZ 52MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 143810

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE