BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HXPE LINER NEUT 48 GG X 32

    MDR report key: 12611695 · Received October 11, 2021

    Report

    Report Number
    0001822565-2021-02900
    Event Type
    Injury
    Date Received
    October 11, 2021
    Date of Event
    November 30, 2020
    Report Date
    August 9, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K151448
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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, G3, H2, H3, H4, H6. REPORTED EVENT WAS CONFIRMED DUE TO THE REVIEW OF MEDICAL RECORDS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: AN INITIAL RIGHT THA WAS PERFORMED. LABS DONE SHOW ELEVATED COBALT LEVELS, AND AN MRI SHOWS PSEUDOTUMOR FORMATION. A REVISION WAS PERFORMED WITH CORROSION FOUND BETWEEN THE HEAD AND STEM, WITH NECROTIC BONE AT THE TROCHANTER CONSISTENT WITH ALTR. INSTABILITY OF THE JOINT WAS ALSO NOTED. THE HEAD AND LINER WERE EXCHANGED WITH ZIMMER PRODUCTS WITHOUT COMPLICATION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED SIGNS OF BEING IMPLANTED WORN / GOUGED FOR THE LINER. REVIEW OF COMPLAINT HISTORY IDENTIFIED NO ADDITIONAL COMPLAINTS FOR THE LINER. COMPLAINTS ARE MONITORED THROUGH MONTHLY COMPLAINT REVIEW IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. ROOT CAUSE UNCHANGED. THIS COMPLAINT WAS CONFIRMED BASED ON THE PROVIDED MEDICAL RECORDS AND RETURNED DEVICES. 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.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). REF 00-8757-048-01 LOT 62777657 SHELL . REF 00-7711-007-20 LOT 62791196 STEM . REF 00-8018-032-02 LOT 62847102 HEAD . CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2021 - 02901. 0001822565 - 2021 - 02902.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 5 YEARS POST IMPLANTATION DUE TO PAIN, ELEVATED METAL IONS, PSEUDOTUMOR FORMATION, AND INSTABILITY. DURING THE REVISION, ACUTE INFLAMMATION AND SYNOVITIS WAS ENCOUNTERED AS WELL AS NECROTIC BONE AROUND THE TROCHANTER CONSISTENT WITH ALTR. CORROSION BETWEEN THE HEAD AND STEM WITH BLACKENED DEBRIS AROUND THE TRUNNION WAS NOTED. THE HEAD AND LINER WERE EXCHANGED WITHOUT COMPLICATION. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508666 HXPE LINER NEUT 48 GG X 32 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 62858176

    Patients

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