BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS FEMORAL BUSHINGS SET

    MDR report key: 7934053 · Received October 4, 2018

    Report

    Report Number
    0001825034-2018-09178
    Event Type
    Injury
    Date Received
    October 4, 2018
    Report Date
    July 16, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: OSS SEGMENTAL FEMORAL COMPONENT, CATALOG # 150355, LOT # 267280; OSS TIBIAL BEARING, CATALOG # 150411, LOT # 312720; OSS FEMORAL BUSHINGS SET, CATALOG # 150477, LOT # 040920; OSS YOKE, CATALOG # 150493, LOT # 991160; OSS TIBIAL BUSHING, CATALOG # 150476, LOT # 581390; OSS NON-MOD TIB PLATE LONG 71, CATALOG # 161043, LOT # 068050; CPS ANCHOR PLUG 12MM, CATALOG # 178402, LOT # 930680; CPS TRANSVERSE PIN 6PK 32MM, CATALOG # 178527, LOT # 785050; CPS SM SPDL WITH PINS 600LBF, CATALOG # 178354, LOT # 925600; CPS NUT CO-CR-MO ALLOY, CATALOG # 178512, LOT # 885860; CPS CENTERING SLEEVE 15MM, CATALOG # 178537, LOT # UNKNOWN; DIAH SEG LOCK SCREW SET, CATALOG # 150481, LOT # 133790; CPS/OSS 5CM TPR ADAPT W/OSS SC, CATALOG # 178711, LOT # 755330; OSS SEGMENTAL STACKING ADAPTER, CATALOG # 150483, LOT # 975100; OSS 5CM DIAPHYSEAL SEGMENT, CATALOG # 150465, LOT # 414310; OSS 3CM DIAPHYSEL SEGMENT, CATALOG # 150464, LOT # 556640; OSS AXLE, CATALOG # 150480, LOT # 584290; OSS POLY LOCK PIN, CATALOG # 150478 ,LOT # 210660. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2018-09174, 0001825034-2018-09175, 0001825034-2018-09181, 0001825034-2018-09183, 0001825034-2018-09418, 0001825034-2018-09420, 0001825034-2018-09421, 0001825034-2018-09422, 0001825034-2018-09423, 0001825034-2018-09424, 0001825034-2018-09425, 0001825034-2018-09426, 0001825034-2018-09428, 0001825034-2018-09429, 0001825034-2018-09430, 0001825034-2018-09433. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A PATIENT UNDERWENT A KNEE ARTHROPLASTY WITH A LIMB SALVAGE SYSTEM THE PATIENT WENT INTO DEEP FLEXION, AGAINST THE SURGEONS ORDERS, AND HEARD AN AUDIBLE POPPING NOISE. THE PATIENT UNDERWENT A REVISION, DURING WHICH IT WAS REPORTED THAT THE COMPRESS NUT WAS RE-TIGHTENED AND THE CONSTRUCT WAS RE-ASSEMBLED USING THE SAME METAL COMPONENTS WITH NEW POLYETHYLENE COMPONENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775617 OSS FEMORAL BUSHINGS SET PROSTHESIS HIP JDI ZIMMER BIOMET, INC. N/A 918980

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R