BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HG-1

    MDR report key: 1054 · Received August 4, 1992

    Report

    Report Number
    32768-1992-00002
    Event Type
    Injury
    Date Received
    August 4, 1992
    Date of Event
    July 10, 1992
    Report Date
    July 20, 1992
    Manufacturer
    ZIMMER, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON JULY 10, 1992, DR. PERFORMED A RIGHT ACETABULAR REVISION AT THE MEDICAL CENTER OF BEAVER COUNTY, PA. THERE WAS ANOTHER PHYSICIAN ASSISTING.. THE PATIENT WAS AGE 77 YEARS. THE PATIENT FELL SIX (6) MONTHS PRIOR, FRACTURING THE MEDIAL WALL AND LOOSENING THE ACETABULAR CUP; RESULTANT MIGRATION. HG I 52MM CUP W/STANDARD LINER-NO CATALOG NUMBER OR LOT NUMBER AVAILABLE. THREE SCREWS- NO SIZES, CAT NO, OR LOT NO AVAILABLE. APPROXIMATELY 10% OF MESH ON SUPERIOR POSTERIOR RIME SHEARED FROM THE SHELL. ALL MESH WAS RETREIVED FROM PATIENT. ONE SCREW BROKE OFF, PARTIALLY RETREIVED. BROKEN END WAS SOLIDLY IMBEDDED IN HOST BONEDEVICE 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.

    Description of Event or Problem · 1

    ON JULY 10TH, 1992, DR. PERFORMED A RIGHT ACETABULAR REVISION AT THE MEDICAL CENTER OF BEAVER COUNTY, BEAVER, PA. ANOTHER DR. ASSISTED. THE PATIENT WAS A 77 YEAR OLD FEMALE. THE PATIENT HAD FALLEN SIX (6) MONTHS PRIOR, FRACTURING THE MEDICAL WALL AND LOOSENING THE ACETABULAR CUP; RESULTANT MIGRATION. HG I 52MM CUP W/STANDARD LINER-NO CATALOG NUMBER OR LOT NUMBER AVAILABLE. THREE (3) SCREWS, NO SIZES, CAT. NO. OR LOT NO. AVAILABLE. APPROXIMATELY 10% OF MESH ON SUPERIOR RIM SHEARED FROM THE SHELL. ALL MESH WAS RETREIVED FROM PATIENT. ONE SCREW BROKE OFF, PARTIALLY RETREIVED. BROKEN END WAS RETREIVED FROM PATIENT. ONE SCREW BROKE OFF, PARTIALLY RETREIVED. BROKEN END WAS SOLIDLY IMBEDDED IN HOST BONEDEVICE 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: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO 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 HG-1 Implant ACETABULAR CUP AND SCREWS HWC ZIMMER, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention