BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM 12/14 TPR FEM HD -4 NK

    MDR report key: 8178691 · Received December 19, 2018

    Report

    Report Number
    3002806535-2018-01279
    Event Type
    Injury
    Date Received
    December 19, 2018
    Report Date
    November 26, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G4, G7, H1, H2, H6, H10. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. IN ORDER TO INVESTIGATE THE MATTER THOROUGHLY ACCESS IS NEEDED TO CERTAIN PATIENT CO-MORBIDITIES, MRIS, CT SCANS, FULL X-RAYS INCLUDING LATERALS (PRE AND POST PRIMARY SURGERY), ROUTINE BLOOD TESTS TO INCLUDE INFLAMMATORY MARKERS, HIP ASPIRATION TO EXCLUDE INFECTION, INTRAOPERATIVE FINDINGS, HISTOLOGICAL FINDINGS AND CONFIRMATION OF ARMD/ALVAL AND RETRIEVALS. INVESTIGATION IS COMPLETED BASED ON CURRENT AVAILABLE INFORMATION. THE LEGAL CASE IS ONGOING. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED, AND SUBSEQUENTLY A SUPPLEMENTAL REPORT WILL BE PROVIDED WHERE DEEMED REQUIRED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM # 1047-20 LOT # 2014030042 ITEM NAME : APICAL PLUG, ITEM # 1016-26 LOT # 050118978 ITEM NAME: POROPALCAL STEM, ITEM # EP-105833 LOT # 772840 ITEM NAME: EPOLY RLC 32MM 10DEG SZ23, ITEM # NOT REPORTED LOT # NOT REPORTED ITEM NAME: UNKNOWN ACETABULAR SHELL. 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

    HIP REVISION DUE TO ELEVATED METAL ION LEVELS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENTS NOTICE AND THE ALLEGATIONS THERE IN ARE UNVERIFIED.

    Description of Event or Problem · 0

    HIP REVISION DUE TO ELEVATED METAL ION LEVELS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENTS NOTICE AND THE ALLEGATIONS THERE IN ARE UNVERIFIED.

    Description of Event or Problem · 0

    HIP REVISION DUE TO ELEVATED METAL ION LEVELS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENTS NOTICE AND THE ALLEGATIONS THERE IN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    HIP REVISION DUE TO ELEVATED METAL ION LEVELS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S NOTICE AND THE ALLEGATIONS THERE IN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019143 32MM 12/14 TPR FEM HD -4 NK HIP PROSTHESIS KWA BIOMET UK LTD. N/A 3034217

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10.