BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS-K DIAPHYSEAL SEGMENT W/ SCREWS - SMOOTH 5 CM

    MDR report key: 6546289 · Received May 4, 2017

    Report

    Report Number
    0001825034-2017-03083
    Event Type
    Injury
    Date Received
    May 4, 2017
    Date of Event
    July 13, 2016
    Report Date
    July 5, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK123501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: OSS(TM) RS AXLE, ITEM #:161035, LOT #: 161035. OSS REINFORCED YOKE, ITEM #: 150493, LOT #: 480480. OSS RS POLY FEMORAL BUSHINGS, ITEM #: 161034, LOT #: 513160. OSS POLY LOCKING PIN, ITEM #: 150478, LOT #: 491230. OSS POLY TIBIAL BUSHING, ITEM #: 150476, LOT #: 507390. OSS DIAPHYSEAL STACKING ADAPTER, ITEM #: 150483, LOT #: 573560. OSS RS SEGMENTAL FEMORAL - LEFT 7CM, ITEM #: 161012, LOT #: 393970. OSS ELLIPTICAL DIAPHYSEAL SEGMENT 3CM, ITEM #: 150461, LOT #: 437280. OSS INTERLOK BOWED IM STEM W/ SCREW 17MM X 150 MM, ITEM #: 150371, LOT # 390980. OSS POLY TIBIAL BEARING 12 MM, ITEM #: 150410, LOT #: 480560. CUSTOMER HAS NOT INDICATED THAT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. LOCATION OF THE PRODUCT IS CURRENTLY UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-03085, 0001825034-2017-03062, 0001825034-2017-03070, 0001825034-2017-03071, 0001825034-2017-03072, 0001825034-2017-03073, 0001825034-2017-03079, 0001825034-2017-03081, 0001825034-2017-03082, 0001825034-2017-03084.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS COMPONENT WAS NOT RELATED TO THE EVENT. THE INITIAL REPORT SHOULD BE VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A TOTAL KNEE ARTHROPLASTY, THE PATIENT UNDERWENT A TOTAL KNEE REVISION DUE TO UNKNOWN REASONS. 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
    325558 OSS-K DIAPHYSEAL SEGMENT W/ SCREWS - SMOOTH 5 CM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS 594670

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R