BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REDUCED SIZE ONCOLOGY SALVAGE SYSTEM- POLY TIBIAL BEARING

    MDR report key: 6442356 · Received March 29, 2017

    Report

    Report Number
    0001825034-2017-02226
    Event Type
    Injury
    Date Received
    March 29, 2017
    Date of Event
    December 15, 2014
    Report Date
    November 17, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KRO
    PMA / PMN Number
    PK021260
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: - OSS POROUS IM STEM 10.5 X 90, ITEM# 150381, LOT 380910. OSS POROUS IM STEM 12.5 X 150, ITEM# 150391, LOT 743770. OSS 3CM DIAPHYSEAL SEGMENT, ITEM# 150464, LOT 674200. OSS 7CM DIAHPYSEAL SEGMENT, ITEM# 150466, LOT 182010. OSS POLY TIBIAL BUSHING, ITEM# 150476, LOT 183840. OSS POLY LOCK PIN, ITEM# 150478, LOT 185100. DIAH SEG LOCK SCREW SET, ITEM# 150481, LOT 858990. OSS SEGMENTAL STACKING ADAPTER, ITEM# 150483, LOT 362240. OSS RS 3 CM RESURF FMRL-RT, ITEM# 161005, LOT 551130. OSS RS 9CM MOD PROX TIB BODY, ITEM# 161027, LOT 630640. OSS REINFORCED YOKE, ITEM# 150493, LOT 911890. OSS RS POLY FEM BUSHINGS SET/2, ITEM# 161034, LOT 186790. OSS RS AXLE, ITEM# 161035, LOT 159990. (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS PRODUCT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 02225.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION DUE TO LOST ROTATION CONTROL FROM YOKE INTERFERENCE AND A BROKEN BEARING APPROXIMATELY 3 YEARS POST IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225538 REDUCED SIZE ONCOLOGY SALVAGE SYSTEM- POLY TIBIAL BEARING PROSTHESIS, KNEE KRO BIOMET ORTHOPEDICS 328390

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| R