BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER

    MDR report key: 17334757 · Received July 17, 2023

    Report

    Report Number
    0002648920-2023-00155
    Event Type
    Injury
    Date Received
    July 17, 2023
    Date of Event
    October 8, 2018
    Report Date
    July 11, 2023
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    UDI-DI
    00889024144875
    PMA / PMN Number
    K953337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2023 - 01886. PROPOSED COMPONENT CODE: MECHANICAL (G04)- HEAD. D10: CAT# 00-2232-004-18; LOT# 63674177; CABLE READY GTR COCR CABLE. CAT#00-2232-004-18; LOT# 63716290; CABLE READY GTR COCR CABLE. CAT# 00-6202-058-22; LOT# 63365727; TM ACET SHELL 58MM CLUSTER. CAT# 00-7713-013-00; LOT# 63675172; M/L TPR KINECTIV STEM SZ 13.5. 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 RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: ADDITIONALLY, IT WAS REPORTED THE PATIENT WAS EXPERIENCING MULTIPLE SUBLUXATION EVENTS PRIOR TO THE REVISION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR ALL ISSUES REPORTED BESIDES THE HEMATOMA. NO PROBLEM WAS FOUND WITH THE DEVICES REGARDING THE HEMATOMA, AS REVIEW BY A HCP DETERMINED IT WAS PROCEDURE RELATED. 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 THE PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 1 YEAR LATER DUE TO PAIN AND HEMATOMA FROM AN UNKNOWN INJURY TO LEFT LEG. DURING THE REVISION NOTED METALLOSIS, SCARRING AND LOCAL TISSUE REACTION. THE HEAD, NECK, AND LINER WERE EXCHANGED, THE CERCLAGE WIRES WERE REMOVED AND I&D TO HEMATOMA WITHOUT COMPLICATIONS. SUBSEQUENTLY AN IRRIGATION AND DEBRIDEMENT WAS PERFORMED APPROXIMATELY SEVEN (7) MONTHS AFTER REVISION DUE TO RECURRENT HEMATOMA WITH 3 PREVIOUS ASPIRATIONS WITH NEGATIVE CULTURES. THE LARGE HEMATOMA WAS EXCISED WITH DRAIN PLACED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1704005 FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 63283898 00889024144875

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H SEE H10 NARRATIVE