BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED

    MDR report key: 10650826 · Received October 8, 2020

    Report

    Report Number
    0001822565-2020-03446
    Event Type
    Injury
    Date Received
    October 8, 2020
    Date of Event
    September 18, 2020
    Report Date
    February 17, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00889024131835
    PMA / PMN Number
    K200823
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO RECURRENT DISLOCATIONS. DURING THE PROCEDURE, SCAR TISSUE WAS DEBRIDED FROM THE FEMORAL NECK AND HEAD. PSEUDOCAPSULE WAS REMOVED. NO OTHER FINDINGS RELATED TO THE REPORTED EVENT WERE NOTED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE EVENT. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). BIOMET CAT#EP-200150 LOT885430 NA ACT ARTIC E1 HIP BRG 28X44MM, ZIMMER CAT#00-8775-028-01 LOT#2993959 NA BIOLOX DELTA FEM HEAD, 28MM, -3.5MM, BIOMET CAT#110010245 LOT#6569107 54 MM G7 OSSEO TI LIMITED HOLE ACETABULAR CUP, BIOMET CAT#110024464 LOT#891800 DUAL MOBILITY ACETABULAR LINER. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE WAS DISCARDED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT RIGHT THA. SUBSEQUENTLY, PATIENT WAS REVISED APPROXIMATELY 7 MONTHS LATER DUE TO RECURRENT DISLOCATIONS. DURING REVISION FROM DISLOCATION, SCAR TISSUE WAS FOUND ON THE STEM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112116 FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 63622660 00889024131835

    Patients

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