BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL MODULAR ACETABULAR SHELL

    MDR report key: 2103025 · Received May 10, 2011

    Report

    Report Number
    1822565-2011-01145
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    March 8, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM MEDWATCH FORM (B)(4). NO X-RAYS HAVE BEEN PROVIDED AND IT CANNOT BE CONFIRMED WHETHER THE COMPONENTS WERE IMPLANTED IN THE CORRECT ORIENTATION. NO SURGICAL REPORT HAS BEEN PROVIDED; IT CANNOT BE ASCERTAINED WHETHER PROPER INSTRUMENTATION AND TECHNIQUE WERE USED OR NOT. PAST MEDICAL HISTORY OF THE PT AND THE ACTIVITY LEVEL ARE UNK. ONE OR COMBINATION OF THE FOLLOWING FACTORS MIGHT HAVE CONTRIBUTED TO THE EVENT: OSTEOLYTIC LESIONS IN THE BONE STOCK SUPPORTING THE POROUS CUP; IMPROPER POSITIONING OF THE COMPONENTS; IMPROPER REAMING OF THE ACETABULUM; IMPROPER SURGICAL TECHNIQUE; HIGH PT ACTIVITY LEVEL. HOWEVER, NO CAUSE ANALYSIS CAN BE DETERMINED WITH CERTAINTY. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. THE RETURNED DEVICES MEET PRINT SPECIFICATIONS WHERE MEASURED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED. THE ACETABULAR CUP DID NOT STAY PRESS FIT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRABECULAR METAL MODULAR ACETABULAR SHELL JDI ZIMMER INC 61175437

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOT #61110834, (B)(4)| CATALOG #00801803602, LOT #61029545,| (B)(4)| VERSYS HIP SYSTEM FEMORAL HEAD:| BONE SCREW SELF-TAPPING: CATALOG #00625006530,| LOT #61044321| POLYETHYLENE LINER: CATALOG #00630505036,| TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED