BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MOM HIP IMPLANT

    MDR report key: 7128369 · Received December 19, 2017

    Report

    Report Number
    0009613350-2017-01787
    Event Type
    Injury
    Date Received
    December 19, 2017
    Report Date
    February 7, 2020
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    PMA / PMN Number
    PNA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS DISCOVERED THAT THIS EVENT WAS FILED UNDER THE INCORRECT MANUFACTURER, ZIMMER GMBH. THE CORRECT MANUFACTURER IS ZIMMER,INC, WARSAW, AS COMMUNICATED IN THE AMENDED INITIAL REPORT SUBMITTED BY ZIMMER, INC, WARSAW ON FEBRUARY 4, 2020 (MFR 0002648920-2020-00070). PLEASE DELETE THIS REPORT INVOLVING "UNKNOWN MOM HIP IMPLANT" AND ZIMMER GMBH FROM YOUR RECORDS. THIS CASE: (B)(4) WILL BE FURTHER REPORTED UNDER MFR 0002648920-2020-00070.

    Description of Event or Problem · 0

    NO EVENT UPDATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. NO TREND ANALYSIS COULD BE PERFORMED AS NO SPECIFIC EVENT INFORMATION IS AVAILABLE. EVENT SUMMARY: PATIENT UNDERWENT PRIMARY SURGERY WITH UNKNOWN MOM HIP IMPLANTS, AND PURSUING LEGAL CLAIM DUE TO UNKNOWN REASONS. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ROOT CAUSE ANALYSIS: NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANT(S) WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT(S) IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. CONCLUSION SUMMARY: AS THE PROBLEM EXPERIENCED BY THE PATIENT AS WELL AS THE PRODUCT IMPLANTED IS UNKNOWN AND NO OTHER INFORMATION IS AVAILABLE IT IS IMPOSSIBLE TO PERFORM A DETAILED ANALYSIS OF THE REPORTED EVENT. THEREFORE, AN EXACT ROOT CAUSE CANNOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    A PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED AN UNKNOWN MOM HIP IMPLANT ON AN UNKNOWN SIDE ON AN UNKNOWN DATE. CURRENTLY, NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906970 UNKNOWN MOM HIP IMPLANT JDI ZIMMER GMBH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other