BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 44MM

    MDR report key: 16983168 · Received May 23, 2023

    Report

    Report Number
    0001825034-2023-01168
    Event Type
    Injury
    Date Received
    May 23, 2023
    Date of Event
    October 3, 2022
    Report Date
    October 20, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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, H3, H6: COMPONENT CODE: MECHANICAL (G04) - HEAD. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. COMPLAINT CONFIRMED BASED ON REVIEW OF MEDICAL RECORDS. REVIEW OF THE DEVICE HISTORY RECORD(S) 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: RIGHT HIP PAIN AFTER RECENT FALL WITH BACK PAIN AND POSTERIOR HIP PAIN WITH POPPING AND INSTABILITY, MILDLY ELEVATED METAL IONS. WELL ALIGNED METAL-ON-METAL HIP ARTHROPLASTY WITH GOOD INGROWTH WITHOUT SINGS OF LOOSENING. ADVERSE LOCAL TISSUE REACTION LINING OF THE INSIDE OF THE JOINT NOTED WITH DARK TISSUES AND THIS WAS COMPLETELY EXCISED. THICK INFLAMED BURSA NOTED OVER THE GREATER TROCHANTER WHICH WAS SCARRED AND WAS EXCISED. UPON ENTERING THE HIP ENCOUNTERED ABUNDANT DARK JOINT FLUID WITH BLACK PARTICLES. 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). D4: X12-171311 INTEGRAL/X POR RED PROX 11MM LOT NUMBER 791970. 139256 M2A-MAGNUM 42-50 TPR INSRT STD LOT NUMBER 000920. US157850 M2A-MAGNUM PF CUP 50ODX44ID LOT NUMBER 929520. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2023 - 01167. 0001825034 - 2023 - 01166. 0001825034 - 2023 - 01165. 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. DEVICE LOCATION IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: H6 COMPONENT CODE: MECHANICAL (G04) - HEAD. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THERE ARE BLACK MARKS ON THE FACE OF THE INSERT ALONG WITH VISIBLE INDENTATION. THE OUTER DIAMETER HAS SCUFFING. REVIEW OF COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM(S) AND NO ADDITIONAL COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION(S). COMPLAINTS ARE MONITORED THROUGH MONTHLY COMPLAINT REVIEW IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION 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

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED PT UNDERWENT A REVISION PROCEDURE 14 YEARS AND 9 MONTHS POST-IMPLANTATION DUE TO PAIN, NOISE, AND INSTABILITY AFTER FALLING AND ELEVATED METAL IONS. DURING THE REVISION PROCEDURE BURSITIS WAS NOTED, ABUNDANT DARK JOINT FLUID WITH BLACK PARTICLES, ALTR AND PSEUDOTUMOR. THE STEM AND CUP WERE WELL FIXED AND REMAINED IMPLANTED. THE HEAD AND THE ADAPTER WERE EXCHANGED WITHOUT COMPLICATIONS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1449344 M2A-MAGNUM MOD HD SZ 44MM PROSTHETIC, HIP KWA ZIMMER BIOMET, INC. N/A 139410

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention| H