BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MLRY-HD POR FMRL 9X150MM

    MDR report key: 15735740 · Received November 4, 2022

    Report

    Report Number
    0001825034-2022-02488
    Event Type
    Injury
    Date Received
    November 4, 2022
    Date of Event
    January 8, 2020
    Report Date
    December 12, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN- UNKNOWN BIOMET MAGNUM CUP, SIZE 50MM-UNKNOWN. UNKNOWN-UNKNOWN 44MM MALLORY HEAD-UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2022 - 02486, 0001825034 - 2022 - 02487. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT LOCATION UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6 COMPONENT CODE: MECHANICAL (G04), STEM. REPORTED EVENT WAS CONFIRMED, VIA MEDICAL RECORDS AND RADIOGRAPHS REVIEWED BY A HEALTH CARE PROFESSIONAL. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED. VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES, DURING MANUFACTURING. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: 157444-M2A-MAGNUM MOD HD SZ 44MM-771660. US157850-M2A-MAGNUM PF CUP 50ODX44ID-920660. 139256-M2A-MAGNUM 42-50 TPR INSRT STD-507180. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 10 YEARS POST IMPLANTATION DUE TO CONCERNS OF METALLOSIS. DURING REVISION, A FAIR AMOUNT OF METAL-STAINED FIBROUS DEBRIS IN THE ANTERIOR ASPECT OF THE CAPSULE WAS ENCOUNTERED AS WELL AS MILD OXIDATION ON THE TRUNNION. THE FEMORAL HEAD AND NECK WERE REPLACED WITH A BIOLOX DELTA HIP SYSTEM WITHOUT COMPLICATIONS AND THE PATIENT TOLERATED THE PROCEDURE WELL. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2528986 MLRY-HD POR FMRL 9X150MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 379420
    2676107 MLRY-HD POR FMRL 9X150MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 379420

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R