BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALANCE PRIMARY HIP 9 X150 RT

    MDR report key: 10270931 · Received July 14, 2020

    Report

    Report Number
    0001825034-2020-02728
    Event Type
    Injury
    Date Received
    July 14, 2020
    Date of Event
    February 27, 2018
    Report Date
    July 21, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. UPDATED: B4, B5, D4, G4, H2, H3, H6. MEDICAL RECORDS RECEIVED NOTED PSEUDOTUMOR REACTION, PAIN, CORROSION AND STRESS SHIELDING. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 28MM M2A MOD HEAD STD NK CAT# 11-163662 LOT# 880950; M2A-TAPER LINER SZ 41/28 CAT# 15-105002 LOT# 043570; M2A-T M/H RAD 2HL SHL 41/54MM CAT# 10-104054 LOT# 980750. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE LOCATION REMAINS UNKNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-02239-2, 0001825034-2019-02238-2.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 15 YEARS POST IMPLANTATION DUE TO PAIN, PSEUDOTUMOR, IN-VIVO CORROSION, BONE REMODELING, ROM LIMITED MOBILITY, AND ELEVATED METAL ION LEVELS. OPERATIVE REPORT FINDINGS INCLUDED MILD TO MODERATE CORROSION AT THE HEAD-NECK JUNCTION AND MINIMAL BONE LOSS. REMAINING BONE WAS QUITE SOFT, APPEARING TO HAVE BEEN SIGNIFICANTLY STRESS SHIELDED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736210 BALANCE PRIMARY HIP 9 X150 RT PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 562610

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE.