BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS INTERLOK IM STEM W/SCREW

    MDR report key: 7367549 · Received March 23, 2018

    Report

    Report Number
    0001825034-2018-02177
    Event Type
    Injury
    Date Received
    March 23, 2018
    Report Date
    March 23, 2018
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 161012 NAME: OSS RS 7 CM MOD SEG FMRL-LT LOT: 376480; 161094 OSS RS 12MM LS TIBIAL BEARING 646750; 150478 OSS POLY LOCK PIN 761760 ; 150483 OSS SEGMENTAL STACKING ADAPTER 725570 ; 150476 OSS POLY TIBIAL BUSHING 695940 ; 161034 OSS RS POLY FEM BUSHINGS SET/2 128100 ; 161035 OSS RS AXLE 502200 ; 150493 OSS REINFORCED YOKE 652900; 150482 OSS 4CM DIAPHYSEAL SEGMENT 950900 ; 150466 OSS 7CM DIAHPYSEAL SEGMENT 660600; 161022 OSS RS NON-MOD PLATE LONG 59 585710. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS:0001825034-2018-01768-1. REPORTED EVENT WAS CONFIRMED THROUGH RADIOGRAPHS RECEIVED. X-RAY REVIEW INDICATED RADIOLUCENCY ALONG THE BONE CEMENT INTERFACE OF THE FEMORAL STEM. STATUS POST DISTAL FEMORAL RESECTION. THERE IS ALSO LUCENCY ALONG THE LATERAL ASPECT OF THE PROXIMAL FEMORAL DIAPHYSIS. THERE IS NO DISLOCATION AND NO FRACTURE SEEN. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 A PATIENT IS EXPERIENCING DISCOMFORT DUE TO A LOOSE FEMORAL STEM, FOLLOWING A LEFT ORTHOPEDIC SALVAGE SYSTEM PROCEDURE. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209100 OSS INTERLOK IM STEM W/SCREW PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 608240

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention