BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR FEMORAL STEM PRESS-FIT

    MDR report key: 10519061 · Received September 10, 2020

    Report

    Report Number
    0001822565-2020-03204
    Event Type
    Injury
    Date Received
    September 10, 2020
    Date of Event
    August 3, 2020
    Report Date
    December 16, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024132658
    PMA / PMN Number
    K182678
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL RECORDS AND RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING : THE PATIENT FELL AND SUSTAINED A FEMORAL PERIPROSTHETIC FRACTURE. PATIENT UNDERWENT AN ORIF AND REVISION. THE ORIF PROCEDURE WAS COMPLETED WITH ZIMMER 2.0 CABLES. CABLE PLACED DISTAL TO LESSER TROCHANTER. ADDITIONAL CABLE TO GET THE SMALLER MORE DISTAL FRAGMENT 3RD CABLE PASSED THROUGH DRILL HOLE OF LESSER TROCHANTER TO PREVENT MIGRATION. THE HEAD AND STEM WERE REPLACED WITH WAGNER REVISION STEM AND A BIOLOX HEAD. THE NEW STEM SAT SLIGHTLY MORE PROUD THAN THE TRIAL (BY A FEW MM). NO OTHER FINDINGS/COMPLICATIONS RELATED TO THE EVENT WERE NOTED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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 · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ZIMMER BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 32/0, TAPER 12/14 CAT#00877503202 LOT#3011774. ZIMMER MODULAR NECK B 12/14 NECK TAPER USE WITH +0 HEADS ONLY CAT#00784802200 LOT#64561290. ZIMMER SHELL POROUS WITH CLUSTER HOLES 54 MM CAT#00620205422 LOT#64333649. ZIMMER LINER STANDARD 32 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS CAT#00630505032 LOT$64489628. ZIMMER BONE SCR 6.5X30 SELF-TAP CAT#00625006530 LOT#64611740. ZIMMER BONE SCR 6.5X30 SELF-TAP CAT#00625006530 LOT#64613278. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE DEVICE BEING DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT THA. SUBSEQUENTLY, THE PATIENT FELL APPROXIMATELY 2 MONTHS LATER SUSTAINING A FEMORAL PERIPROSTHETIC FRACTURE. THE PATIENT UNDERWENT AN ORIF AND REVISION 3 DAYS AFTER THE FALL. THE STEM, NECK, AND HEAD WERE REMOVED AND REPLACED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981019 MODULAR FEMORAL STEM PRESS-FIT PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64524364 00889024132658

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R