BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS 5CM TAPERED DIAPH SEGMENT

    MDR report key: 20085023 · Received August 28, 2024

    Report

    Report Number
    0001825034-2024-02098
    Event Type
    Injury
    Date Received
    August 28, 2024
    Report Date
    February 4, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304674905
    PMA / PMN Number
    K141331
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) . D10-MEDICAL PRODUCT CPS SM SHT SPDL W PINS 600LBF ITEM# 178366 LOT# 567750. CPS SHORT ANCHOR PLUG 12MM ITEM# 178554 LOT# 064040. CPS TRANSVERSE PIN 6PK 32MM ITEM# 178527 LOT# 197690. CPS NUT CO-CR-MO ALLOY ITEM# 178512 LOT# 967810. CPS CENTERING SLEEVE 15MM ITEM# 178537 LOT# 716810. CPS TAPER LOCKING CAP / OSS SC ITEM# 178710 LOT# 779270. OSS POLY BUMPER LOCK PIN ITEM# 150510 LOT# 695180. OSS POLY LOCK PIN ITEM# 150478 LOT# 747330. OSS 9CM TAPERED DIAPH SEGMENT ITEM# 151840 LOT# 018020. OSS RS AXLE ITEM# 161035 LOT# 394270. OSS RS POLY FEM BUSHINGS SET/2 ITEM# 161034 LOT# 507840. CPS/OSS 5CM TPR ADAPT W/OSS SC ITEM# 178711 LOT# 708850. OSS POLY TIBIAL BUSHING ITEM# 150476 LOT# 690760. OSS REINFORCED YOKE ITEM# 150493 LOT# 510100. OSS SEGMENTAL STACKING ADAPTER ITEM# 150483 LOT# 600600. OSS RS 12MM LS TIBIAL BEARING ITEM# 161094 LOT# 270810. OSS RS 7 CM MOD SEG FMRL-RT ITEM# 161011 LOT# 031310. H3- CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL, AND IT WAS DETERMINED FURTHER REVIEW WOULD NOT ENHANCE THE INVESTIGATION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO RELATED DEVIATIONS / ANOMALIES IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT IS NOT CONFIRMED. IF ANY FURTHER INFORMATION IS RECEIVED WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WILL NEED A REVISION DUE TO COMPRESS FAILURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180691 OSS 5CM TAPERED DIAPH SEGMENT PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 131140 00880304674905

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H11.