BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS POROUS IM STEM 14.5 X 150

    MDR report key: 11313309 · Received February 11, 2021

    Report

    Report Number
    0001825034-2021-00442
    Event Type
    Injury
    Date Received
    February 11, 2021
    Date of Event
    July 8, 2016
    Report Date
    June 8, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K123501
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). AN ADDITIONAL MDR REPORT WAS FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034 - 2021 - 01730. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. MEDICAL RECORDS IDENTIFIED THE FOLLOWING: 44YO, PAINFUL LEFT HIP, HISTORY OF INSTABILITY AND LLD. PAIN AND LLD FROM PROSTHESIS, ALSO LOW BACK AND SCIATIC TYPE PAIN. REMOVED POLY LINER, DUE TO NEED TO SHORTEN LL BY 2CM, CONSTRAINED LINER, LOCKING RING IMPACTED. NEW FEMORAL PROXIMAL BODY PLACED, AND +0, 28MM BIOLOX DELTA CERAMIC FEMORAL HEAD. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED, HOWEVER A COMPETITOR LINER WAS IMPLANTED DURING THE REVISION IN 2013 AND THIS WOULD BE CONSIDERED OFF LABEL USE, IT IS UNKNOWN IF THIS COMPATIBILITY ISSUE WOULD CAUSED OR CONTRIBUTED TO THE EVENTS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM #: UNKNOWN UNKNOWN HEAD LOT #: UNKNOWN; ITEM #: UNKNOWN UNKNOWN COMPETITOR LINER LOT #: UNKNOWN; ITEM #: UNKNOWN UNKNOWN COMPETITOR CUP LOT #: UNKNOWN; 150458 OSS FINN MOD PROX FMRL 605670; 150464 OSS 3CM DIAPHYSEL SEGMENT 258720; 150461 OSS 3CM ELLIP DIAPHYSEAL 519620; 150483 OSS SEGMENTAL STACKING 281540; 6704-8-240 STRYKER CABLE 2.0MM 40620305; 6704-4-020 STRYKER CABLE SLEEVE 41165504. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE 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 FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2021 - 00443.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT LEFT THA ON UNKNOWN DATE, AND UNDERWENT REVISION WITH ALL COMPONENTS EXPLANTED. THE PATIENT EXPERIENCED PAIN, INSTABILITY, LLD OF LEFT HIP AND UNDERWENT A 2ND REVISION. DURING THE REVISION IT WAS NOTED THAT A SCREW WAS STRIPPED AND UNABLE TO BE REMOVED AS WELL AS NOTED INTERBODY SEGMENT HAD COLD WELDED TO DISTAL SEGMENTAL COMPONENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211957 OSS POROUS IM STEM 14.5 X 150 PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 249710

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R