BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS DIAPHYSEAL SEGMENT

    MDR report key: 7934133 · Received October 4, 2018

    Report

    Report Number
    0001825034-2018-09428
    Event Type
    Injury
    Date Received
    October 4, 2018
    Report Date
    July 16, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK123501
    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). CONCOMITANT MEDICAL PRODUCTS: OSS SEGMENTAL FEMORAL COMPONENT, CATALOG # 150355, LOT # 267280. 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-MODULAR LONG TIBIAL BASEPLATE, CATALOG # 161043, LOT # 068050. COMPRESS DEVICE SEGMENTAL ANCHOR PLUG, CATALOG # 178402, LOT # 930680. COMPRESS TRANSVERSE PIN, CATALOG # 178527, LOT # 785050. COMPRESS ANTI-ROTATION SPINDLE, CATALOG # 178354, LOT # 925600. COMPRESS NUT, CATALOG # 178512, LOT # 885860. COMPRESS CENTERING SLEEVE, CATALOG # 178537, LOT # UNKNOWN. OSS DIAPHYSEAL LOCKING SCREW SET, CATALOG # 150481, LOT # 133790. COMPRESS TAPER ADAPTER, CATALOG # 178711, LOT # 755330. OSS DIAPHYSEAL STACKING ADAPTOR, CATALOG # 150483, LOT # 975100. OSS DIAPHYSEAL SEGMENT, CATALOG # 150464, LOT # 556640. OSS AXLE, CATALOG # 150480, LOT # 584290. OSS LOCKING 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, 0001825034-2018-09178, 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, 0001825034-2018-09429, 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
    776637 OSS DIAPHYSEAL SEGMENT HIP PROSTHESIS JDI ZIMMER BIOMET, INC. N/A 414310

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R