BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM MOD HD STD NECK TP1 TAPER

    MDR report key: 19258104 · Received May 7, 2024

    Report

    Report Number
    0001825034-2024-01147
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    April 15, 2024
    Report Date
    August 22, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDG
    PMA / PMN Number
    K942479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4; B5; D4; G3; H2; H3; H6. PROPOSED COMPONENT CODE: MECHANICAL (G04) ¿ HEAD. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE PROVIDED FOR THE ORIGINAL HIP PROCEDURE. NO MEDICAL RECORDS WERE PROVIDED FOR THE UNKNOWN REVISION. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: A RIGHT HIP ARTHROPLASTY. THERE IS ECCENTRIC HEAD POSITION REFLECTING POLYETHYLENE WEAR. THERE IS NO FRACTURE DISLOCATION OR LOOSENING. RADIOLUCENCY REFLECTS OSTEOLYSIS. THE COMPLAINT WAS CONFIRMED DUE ON THE EVALUATION OF THE PROVIDED X-RAY. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# RD115654 LOT# 261080 MODIFIED UNIVERSAL II 54MM CAT# 11-105904 LOT# 476070 ARCOM 28MM RNGLOC LNR HWALL 24 CAT# 103531 LOT# 952220 TI LOW PROFILE SCREW 6.5X20MM CAT# 103531-00 LOT# 772360 TI LOW PROFILE SCREW 6.5X20MM CAT# 103203 LOT# 472800 TAPERLOC POR FMRL 9X137 THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY FIFTEEN(15) YEARS POST IMPLANTATION DUE TO UNKNOWN REASONS. DURING THE REVISION, THE HEAD COMPONENT WAS REMOVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642826 28MM MOD HD STD NECK TP1 TAPER PROSTHESIS, HIP JDG ZIMMER BIOMET, INC. N/A 885140

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R