BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM DIA COCR MOD HD +9MM NK

    MDR report key: 10436620 · Received August 21, 2020

    Report

    Report Number
    0001825034-2020-03286
    Event Type
    Injury
    Date Received
    August 21, 2020
    Report Date
    November 3, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K974558
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, G4, H2, H3, H6 CORRECTED: E1 ADDITIONAL MDR REPORTS WAS FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 03997. 0001825034 - 2020 - 03998. 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. RADIOGRAPHS IDENTIFIED THE FOLLOWING: THE ARTHROPLASTY COMPONENTS ARE ANATOMICALLY ALIGNED WITHOUT DISLOCATION OR FRACTURE. THERE IS EXTENSIVE OSTEOLYSIS GREATEST IN GRUEN ZONES 1 AND 7 OF THE FEMORAL IMPLANT AND AT THE INFERIOR ACETABULAR CUP, AS WELL AS QUESTIONABLY ALONG THE MORE LATERAL CUP FIXATION SCREW. EXTENSIVE OSTEOLYSIS OF THE LEFT HIP ARTHROPLASTY. 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

    IT WAS REPORTED BY THE (B)(6) THE PATIENT UNDERWENT AN INITIAL THA AT AN UNKNOWN DATE. THE PATIENT HAS BEEN INDICATED FOR A REVISION, HOWEVER, A REVISION HAS NOT BEEN REPORTED. RADIOGRAPHS IDENTIFIED EXTENSIVE OSTEOLYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 12-105903 RNGLC +5MM LNR 28MM HWALL SZ23 974220. ITEM #: UNKNOWN; UNKNOWN STEM LOT #: UNKNOWN. 113847 TITANIUM SCREW LOW PROF 5X35MM 298515. 113847 TITANIUM SCREW LOW PROF 5X35MM 298515. 103532 BM ACET LP DOME SCW TI S/TAP D IA6.5X25MM 206010. 103532 BM ACET LP DOME SCW TI S/TAP D IA6.5X25MM 586140. 11-103560 UNIV RNGLC SHL 60MM/L23 353810. 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 - 2020 - 03287.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE 411 GROUP THE PATIENT UNDERWENT AN INITIAL THA AT AN UNKNOWN DATE. THE PATIENT HAS BEEN INDICATED FOR A REVISION, HOWEVER, A REVISION HAS NOT BEEN REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900655 28MM DIA COCR MOD HD +9MM NK PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 578400

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SEE H10