BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS SEGMENTAL FEMORAL COMPONENT

    MDR report key: 7934050 · Received October 4, 2018

    Report

    Report Number
    0001825034-2018-09174
    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

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: OSS TIBIAL BEARING CATALOG # 150411, LOT # 312720; OSS FEMORAL BUSHINGS SET CATALOG # 150477, LOT # 040920; OSS FEMORAL BUSHINGS SET CATALOG # 150477, LOT # 918980; 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: 0001825034-2018-09175; 0001825034-2018-09178; 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
    774332 OSS SEGMENTAL FEMORAL COMPONENT HIP PROSTHESIS JDI ZIMMER BIOMET, INC. N/A 267280

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R