BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER, INC.

    MDR report key: 1229 · Received August 24, 1992

    Report

    Report Number
    32474-1992-00003
    Event Type
    Injury
    Date Received
    August 24, 1992
    Date of Event
    July 20, 1992
    Report Date
    August 6, 1992
    Manufacturer
    ZIMMER, INC.
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE POLYETHYLENE DISASSOCIATED FROM THE METAL BACKED POLY PATELLA DURING ROUTIONE ACTIVITY. PHYSICIAN THEN PERFORMED A REVISION SURGERY ON 4/15/92 AT RHODE ISLAND HOSPITAL-PROVIDENCEDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER, INC. Implant MG I POLYETHYLENE PATELLA COMPONET ZIMMER, INC. SIZE 38MM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention