BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS 3CM RESURF FEMORAL LT

    MDR report key: 11673398 · Received April 15, 2021

    Report

    Report Number
    0001825034-2021-01099
    Event Type
    Injury
    Date Received
    April 15, 2021
    Date of Event
    March 23, 2021
    Report Date
    May 5, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 RELATED DEVIATIONS / ANOMALIES IDENTIFIED. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2021-01098, 0001825034-2021-01100. MEDICAL PRODUCT OSS NON-MOD TIB PLATE LONG 71 LONG ITEM# 161043 LOT# 742520; OSS CEMENTED IM STEM 17X150 50 ITEM# 150371 LOT# 818190; OSS AXLE ITEM# 150480 LOT# 415380; OSS POLY LOCK PIN ITEM# 150478 LOT# 489220; OSS POLY TIBIAL BUSHING ITEM# 150476 LOT# 303530; OSS POLY FEMORAL BUSHINGS ITEM# 150477 LOT# 140070; OSS TIBIAL POLY BEARING 12MM ITEM# 150410 LOT# 368590; OSS REINFORCED YOKE ITEM# 150493 LOT# 111640. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT HAS BEEN DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY SIX AND A HALF YEARS POST IMPLANTATION DUE TO FEMORAL AND TIBIAL LOOSENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571602 OSS 3CM RESURF FEMORAL LT PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 578530

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R