BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS 7CM SEGMENTAL FEMORAL LT

    MDR report key: 6968168 · Received October 23, 2017

    Report

    Report Number
    0001825034-2017-09503
    Event Type
    Injury
    Date Received
    October 23, 2017
    Date of Event
    April 11, 2017
    Report Date
    March 2, 2018
    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
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 150482 OSS 4CM DIAPHYSEAL SEGMENT LOT 012180, 178400 CPS ANCHOR PLUG 10MM LOT 251130, 161041 OSS RS NON-MOD PLT LONG 71 LOT 211290, 178526 CPS TRANSVERSE PIN 6PK 28MM LOT 259380, 150476 OSS POLY TIBIAL BUSHING LOT 528280, 178512 CPS NUT CO-CR-MO ALLOY LOT 606520, 150411 OSS TIBIAL POLY BEARING 14MM LOT 772400, 150493 OSS REINFORCED YOKE LOT 0000241415, 150478 OSS POLY LOCK PIN LOT 0000156857, 150480 OSS AXLE LOT 625130, 150477 OSS POLY FEMORAL BUSHINGS 2PK LOT 047020, 178742 CPS MT XS SPNDL 400LB PINS LOT 707500, 178535 CPS CENTERING SLEEVE 13MM LOT 319810, 150483 OSS SEGMENTAL STACKING ADAPTER LOT 170860, 178710 CPS TAPER LOCKING CAP / OSS SC LOT 396730, 178711 CPS/OSS 5CM TPR ADAPT W/OSS SC LOT 533150. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. XRAYS NOTED THERE IS A SMALL ROUNDED METALLIC FOCUS WITHIN HOFFA'S FAT JUST ANTERIOR TO THE FEMORAL COMPONENT IN THE INTRA-ARTICULAR HINGE, POSSIBLY A LOOSE BODY WHICH WOULD SUGGEST IMPLANT DISASSEMBLY. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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). MEDICAL PRODUCTS - UNKNOWN OSS TIBIAL TRAY, UNKNOWN OSS BEARING. REPORT SOURCE (B)(6). IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT AN ORTHOPEDIC SALVAGE PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY TEN YEARS POST-IMPLANTATION DUE TO LOOSENING OF THE LAST FIXATION SCREW THROUGH THE FEMORAL BLOCK OF THE DISTAL FEMORAL RESECTION PROSTHESIS. THE SURGEON WAS CONCERNED THAT THE LOOSE SCREW WAS CAUSING BLOCKAGE OF THE KNEE JOINT AND COULD POSSIBLY DAMAGE THE METAL PROSTHETIC SURFACE AND ARTICULAR SURFACE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 5 YEARS POST INITIAL KNEE SURGERY, THE PATIENT HAS A A BLOCKED KNEE JOINT DUE TO LOOSENING OF A LOCKING SCREW AT DISTAL FEMUR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748748 OSS 7CM SEGMENTAL FEMORAL LT JDI ZIMMER BIOMET, INC. N/A 691020

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other