BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 TYPE1 PPS SO 16.0

    MDR report key: 7473782 · Received April 30, 2018

    Report

    Report Number
    0001825034-2018-03004
    Event Type
    Injury
    Date Received
    April 30, 2018
    Date of Event
    January 8, 2018
    Report Date
    July 3, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK101086
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    UDI: (B)(4). 010000665 G7 PPS LTD ACET SHELL 3423835, 010000747 G7 NEUTRAL ARCOMXL LNR 3373862, S031140 SELEX/MAGNUM MOD H 962190. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF REVISION OPERATIVE REPORT RECEIVED. SURGEON REPORTED THAT FEMUR AND CUP WERE IN POSITION, AND STABLE FREE OF LOOSENING. INSPECTED THE POLY AND WAS IN PRISTINE CONDITION. THERE WAS A NOTE OF NO TO LITTLE FLUID IN THE JOINT CAPSULE. SURGEON NOTED SOME BLACK CORROSIVE DEBRIS AT THE HEAD AND NECK JUNCTION AND WAS REMOVED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP REVISION ARTHROPLASTY APPROXIMATELY THREE YEARS TWO MONTHS POST IMPLANTATION DUE TO PAIN, INFLAMMATORY MARKERS, AND ELEVATED METAL IONS. ALL THE INTRAOPERATIVE CULTURES AND PATHOLOGY SAMPLES CAME NEGATIVE FOR INFECTION. PRIOR THE REVISION, THE PATIENT REPORTED INCREASED RELIANCE ON WALKING AIDS EVENTUALLY REQUIRING THE USE OF A WHEELCHAIR. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: UNKNOWN, UNKNOWN HEAD 40 MM, UNKNOWN. UNKNOWN, UNKNOWN STEM, UNKNOWN. UNKNOWN, UNKNOWN LINER, UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001825034-2018-03005.: HOSPITAL DISCARDED AS BIOHAZARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP REVISION ARTHROPLASTY APPROXIMATELY 3.5 YEARS POST IMPLANTATION DUE TO PAIN, WEAKNESS, AND METALLOSIS SECONDARY TO TRUNNIONOSIS. PRIOR TO THE REVISION, THE PATIENT REPORTED INCREASED RELIANCE ON WALKING AIDS EVENTUALLY REQUIRING THE USE OF A WHEELCHAIR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314741 TPRLC 133 TYPE1 PPS SO 16.0 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 3363752

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R