BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC/X POR NC LAT 18X170

    MDR report key: 16631806 · Received March 28, 2023

    Report

    Report Number
    0001825034-2023-00677
    Event Type
    Injury
    Date Received
    March 28, 2023
    Date of Event
    September 29, 2021
    Report Date
    June 23, 2023
    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
    NY, 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 D4: EXPIRATION DATE. G3 G6 H2 H4 H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) - STEM. H10. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: AN INITIAL LEFT HIP THA WAS PERFORMED ON (B)(6) 2007. A REVISION OCCURRED ON (B)(6) 2021 DUE TO PAIN AND ELEVATED METAL IONS. DURING THE REVISION, THE TISSUES WERE BLACKISH IN COLOR AND THE TAPER ADAPTOR WAS COLD WELDED TO THE STEM. ADDITIONALLY, THE CUP WAS LOOSE WITH NO BONY INGROWTH. ALL IMPLANTS BUT THE STEM WERE EXPLANTED WITH NEW ONES PLACED. A DEFINITIVE ROOT CAUSE CANNOT 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

    (B)(4). CONCOMITANT MEDICAL PRODUCTS:PRODUCT ID: US157862 M2A-MAGNUM PF CUP 62ODX56ID. LOT NUMBER 171630. 139264 M2A-MAGNUM 52-60MM TPR INSRT-6 LOT NUMBER 531940 X11-180318 BI-METRIC/X POR NC LAT 18X170. LOT NUMBER 953140. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-00676, 0001825034-2023-00675, 0001825034-2023- 00674. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, AS SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED PT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 14 YEARS POST-IMPLANTATION DUE TO PAIN AND INCREASED METAL IONS. DURING THE REVISION SURGERY, BLACK SYNOVIAL TISSUE WAS FOUND, THE TAPER ADAPTER WAS COLD WELDED TO THE STEM, LOOSE ACETABULAR CUP WITH NO BONY GROWTH POSTERIORLY AND BLACK DISCOLORATION TO THE ACETABULAR BONE WERE ALSO FOUND. ALL COMPONENTS WERE EXCHANGED WITHOUT COMPLICATIONS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555786 BI-METRIC/X POR NC LAT 18X170 PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A 953140

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Unknown Hospitalization| R PLEASE SEE H10