BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS CEMENTED IM STEM 15MMX90MM

    MDR report key: 18083972 · Received November 7, 2023

    Report

    Report Number
    0001825034-2023-02595
    Event Type
    Injury
    Date Received
    November 7, 2023
    Report Date
    February 14, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304238916
    PMA / PMN Number
    K123501
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS / ANOMALIES IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. COMPLAINT IS NOT CONFIRMED. IF ANY FURTHER INFORMATION IS RECEIVED WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. H6: COMPONENT CODE: PROPOSED COMPONENT (ANNEX G) CODE IS: - MECHANICAL (G04) - STEM.

    Additional Manufacturer Narrative · 0

    (B)(4). D10- MEDICAL PRODUCT OSS TIBIAL POLY BEARING 12MM ITEM# 150410 LOT# 511170, OSS NON-MOD TIB PLATE LONG 67 ITEM# 150420 LOT# 814970, OSS 7CM SEG ELLIPT FEMORAL LT ITEM# 150357 LOT# 122420, OSS REINFORCED YOKE ITEM# 150493 LOT# 255350, OSS POLY TIBIAL BUSHING ITEM# 150476 LOT# 826760, OSS POLY FEMORAL BUSHINGS ITEM# 150477 LOT# 365640, OSS AXLE ITEM# 150480 LOT# 607850, OSS POLY LOCK PIN ITEM# 150478 LOT# 899240. G2- POLAND. H3- CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UPPER STEM WAS MISPLACED CAUSING MOBILITY ISSUES AND BONE DAMAGE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247525 OSS CEMENTED IM STEM 15MMX90MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 805090 00880304238916

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SEE H10.