BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW DVO DRIVE

    MDR report key: 1901 · Received December 2, 1992

    Report

    Report Number
    33448-1992-00014
    Event Type
    Injury
    Date Received
    December 2, 1992
    Date of Event
    November 17, 1992
    Report Date
    November 19, 1992
    Manufacturer
    HOWMEDICA, INC.
    Product Code
    LRZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    TIBIAL COMPONENT SUBSIDED ANTERIORLY. PATELLA COMPONENT DELAMINATED. REPLACED WITH STEMMED BASEPLATE CEMENTED, REVISION INSERT-EXCELLENT RESULT. TIBIAL COMPONENT TO SMALL OR NO ANTERIOR CORTICAL CONTACT. PATELLA WAS RESECTED ON A 10 DEGREE ANGLE SUPERIORLYINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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 NOT USED AS LABELED/INDENDED.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 SCREW DVO DRIVE Implant PCA KNEE LRZ HOWMEDICA, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention