BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR MOD HD -3MM

    MDR report key: 15698615 · Received October 31, 2022

    Report

    Report Number
    0001825034-2022-02442
    Event Type
    Injury
    Date Received
    October 31, 2022
    Date of Event
    October 11, 2022
    Report Date
    November 23, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K032396
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN STEM, CAT #:131150 - MH SOLID SHELL HA/PC 50MM LN23 - LOT #: 2423032, UNKNOWN LINER. FOREIGN SOURCE: AUSTRALIA. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-02441. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, AS SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: COMPONENT CODE: MECHANICAL (G04) - HEAD: VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE LINER HAS DAMAGE TO THE OUTER ARTICULATION SURFACE. NO WEAR CAN BE SEEN ON THE INNER SURFACE IN THE PROVIDED PICTURE. ALL COMPONENTS COVERED IN BIO-DEBRIS; NO ADDITIONAL DETAILS CAN BE SEEN ON THE PROVIDED IMAGES. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICES ARE USED FOR TREATMENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS/THESE ITEM(S) AND THE REPORTED PART AND LOT COMBINATION(S). RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THERE IS ABNORMAL SUPEROLATERAL SUBLUXATION OF THE FEMORAL HEAD WITHIN THE CUP. BONE QUALITY IS OSTEOPENIC. THERE IS MARKED LINER WEAR WITH MALALIGNMENT OF THE FEMORAL HEAD WITHIN THE CUP AS NOTED. RADIOLUCENCY IS PRESENT ALONG THE PROXIMAL FEMUR CONSISTENT WITH OSTEOLYSIS. THE MALALIGNMENT/SUBLUXATION IS SECONDARY TO MARKED LINER WEAR. WHILE METALLOSIS IS NOT SEEN RADIOGRAPHICALLY, THIS WOULD CONTRIBUTE TO THE OSTEOLYSIS NOTED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 11 YEARS POST IMPLANTATION DUE TO THE HEAD WEARING INTO THE LINER CAUSING METALLOSIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2948628 36MM COCR MOD HD -3MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. NI 506070

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R