BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM PF CUP 58MM O.D. X 52MM I.D.

    MDR report key: 6045591 · Received October 20, 2016

    Report

    Report Number
    0001825034-2016-04226
    Event Type
    Injury
    Date Received
    October 20, 2016
    Date of Event
    December 18, 2008
    Report Date
    September 29, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-04224 / 04226).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: CONCOMITANT PRODUCTS ¿ M2A MAGNUM MODULAR HEAD P/N 157450 L/N UNKNOWN; M2A MAGNUM PF CUP P/N US157860 L/N 033780; TAPERLOC POR FEMORAL P/N 103205 L/N 527470. REPORTED EVENT WAS CAN CONFIRMED VIA OPERATIVE NOTES RECEIVED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO IMPROPER REMAINING THAT DEVIATED FROM THE RECOMMENDED SURGICAL TECHNIQUE. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. 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 · 1

    DURING AN INITIAL LEFT HIP ARTHROPLASTY, THE ACETABULAR CUP WAS IMPACTED AND SUBSEQUENTLY REMOVED AS IT WAS FOUND TO BE LOOSE. ANOTHER CUP OF A LARGER SIZE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694392 M2A MAGNUM PF CUP 58MM O.D. X 52MM I.D. PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 427890

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention