BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS RS POLY TIBIAL BEARING 12

    MDR report key: 6871238 · Received September 15, 2017

    Report

    Report Number
    0001825034-2017-07137
    Event Type
    Injury
    Date Received
    September 15, 2017
    Date of Event
    December 15, 2014
    Report Date
    November 10, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    PK021260
    Removal / Correction Number
    N/A
    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 FILED TO RELAY THIS REPORT IS A DUPLICATE OF 0001825034-2017-02226.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: OSS POROUS IM STEM 10.5 X 90 CATALOG #: 150381 LOT #: 380910; OSS POROUS IM STEM 12.5 X 150 CATALOG #: 150391 LOT #: 743770; OSS 3CM DIAPHYSEL SEGMENT CATALOG #: 150464 LOT #: 674200 ; OSS 7CM DIAHPYSEAL SEGMENT CATALOG #: 150466 LOT #: 182010; OSS POLY TIBIAL BUSHING CATALOG #: 150476 LOT #: 183840; OSS POLY LOCK PIN CATALOG #: 150478 LOT #: 185100; DIAH SEG LOCK SCREW SET CATALOG #: 150481 LOT #: 858990; OSS SEGMENTAL STACKING ADAPTER CATALOG #: 150483 LOT #: 362240; OSS REINFORCED YOKE CATALOG #: 150493 LOT #: 911890; OSS RS 3 CM RESURF FMRL-RT CATALOG #: 161005 LOT #: 551130; OSS RS 9CM MOD PROX TIB BODY CATALOG #: 161027 LOT #: 630640; OSS RS POLY FEM BUSHINGS SET/2 CATALOG #: 161034 LOT #: 186790; OSS RS AXLE CATALOG #: 161035 LOT #: 159990. 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 THAT THE PATIENT WAS REVISED TO ADDRESS A BROKEN BEARING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT AN ORTHOPEDIC SALVAGE PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION APPROXIMATELY ONE AND HALF YEARS POST-IMPLANTATION DUE TO FRACTURED POLYETHYLENE BEARING WHICH CAUSED THE PATIENT PAIN. THE POLYETHYLENE BEARING AND ORTHOPEDIC SALVAGE SYSTEM ASSEMBLY PRODUCTS WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648809 OSS RS POLY TIBIAL BEARING 12 PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 328390

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R