BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM EXTENSION STRAIGHT LONG 14MM DIA X 155MM LENGTH(COMBINED LENGTH 200MM)

    MDR report key: 6195614 · Received December 21, 2016

    Report

    Report Number
    0001822565-2016-04777
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    November 30, 2017
    Report Date
    August 9, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM NAME: FEMORAL COMPONENT CEMENTED SIZE C RIGHT, ITEM NUMBER: 00588001302, LOT NUMBER: 61077463. ITEM NAME: PRC AGMT BLOCK DIST SZ C 5MM, ITEM NUMBER: 00599003310*OP1000, LOT NUMBER: 60969421. ITEM NAME: PRC AGMT BLOCK DIST SZ C 5MM, ITEM NUMBER: 00599003310*OP1000, LOT NUMBER: 61173797 ITEM NAME: ARTICULAR SURFACE HINGE POST EXTENSION SIZE C 14 MM, ITEM NUMBER: 00588003014, LOT NUMBER: 61091165. ITEM NAME: TIBIAL COMPONENT PRECOAT SIZE 2, ITEM NUMBER: 00588000200, LOT NUMBER: 61170223. ITEM NAME: STEM EXTENSION SHARP FLUTED 11MM DIA X 75MM LENGTH, ITEM NUMBER: 00598801511, LOT NUMBER: 607885156.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(6). NO PRODUCT WAS RETURNED. VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. BASED ON THE INFORMATION AVAILABLE, A DEFINITIVE ROOT CAUSE CANNOT 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2017-05573, 0001822565-2017-05576, 0001822565-2017-05575, 0001822565-2016-04777.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A FRACTURE OF THE CEMENTED FEMORAL SHAFT AT THE RHK FEMUR COMPONENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO A FRACTURE OF THE FEMORAL SHAFT APPROXIMATELY SEVEN YEARS POST IMPLANTATION. X-RAYS INDICATED SLIGHT ANTERIOR DISPLACEMENT OF THE DISTAL FEMORAL COMPONENT, OSSEOUS RADIOLUCENCY OF LATERAL FEMORAL CONDYLE, RADIOLUCENCY AT THE TIBIAL TRAY, TIBIAL STEM SHOWS LOOSENING, AND GENERALIZED OSTEOPENIA AND HETEROTOPIC OSSIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846008 STEM EXTENSION STRAIGHT LONG 14MM DIA X 155MM LENGTH(COMBINED LENGTH 200MM) PROSTHESIS, KNEE JWH ZIMMER, INC. N/A 60372674

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R