BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER STANDARD 3.5 MM OFFSET 36 MM

    MDR report key: 18596121 · Received January 29, 2024

    Report

    Report Number
    0001822565-2024-00285
    Event Type
    Injury
    Date Received
    January 29, 2024
    Date of Event
    November 23, 2022
    Report Date
    February 29, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    008890241237632
    PMA / PMN Number
    K002960
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 650-1057 LOT# 3062923 CER BIOLOXD OPTION HD 36MM. CAT# 00620205022 LOT# 64724183 SHELL POROUS WITH CLUSTER HOLES 50 MM. CAT# 650-1064 LOT# 3053196 CER OPTION TYPE 1 TPR SLEVE -6. CAT# 51104090 LOT# 6763068 FEMORAL STEM. PRODUCT REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: APPROXIMATELY ONE YEAR AFTER AN INITIAL RIGHT TOTAL HIP ARTHROSCOPY, THE PATIENT EXPERIENCED A DISLOCATION AND UNDERWENT A CLOSED REDUCTION IN THE EMERGENCY DEPARTMENT. NO FURTHER COMPLICATIONS WERE NOTED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. THE ISSUE WAS CONFIRMED BASED ON THE PROVIDED MEDICAL RECORDS; HOWEVER, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY ONE YEAR POST IMPLANTATION OF A RIGHT HIP ARTHROPLASTY, THE PATIENT EXPERIENCED A DISLOCATION. THE HIP WAS SUCCESSFULLY REDUCED IN THE EMERGENCY DEPARTMENT AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. ALL OF THE COMPONENTS REMAIN IMPLANTED AND THERE ARE NO REPORTS OF PAIN AND NO DIFFICULTIES WITH ACTIVITIES OF DAILY LIVING.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797957 LINER STANDARD 3.5 MM OFFSET 36 MM PROTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64875045 008890241237632

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H