BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCR 6.5X30 SELF-TAP

    MDR report key: 11006423 · Received December 15, 2020

    Report

    Report Number
    0002648920-2020-00526
    Event Type
    Injury
    Date Received
    December 15, 2020
    Date of Event
    November 16, 2020
    Report Date
    June 11, 2021
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    K934765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. OPERATIVE NOTES WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL.   THE ROOT CAUSE OF THE REPORTED EVENT CAN BE TRACED TO USER ERROR. IT WAS CONFIRMED BY THE SURGEON THAT THE SCREWS WERE INCORRECTLY POSITIONED DURING THE INITIAL PROCEDURE RESULTING IN THE REPORTED PATIENT HARMS. 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). CONCOMITANT MEDICAL PRODUCTS: ITEM# 00877503601 / ITEM NAME: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, ø 36/-3.5, TAPER 12/14 / LOT#3013180. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2020 - 03994, 0001822565 - 2020 - 03995, 0002648920 - 2020 - 00515, 0001822565 - 2020 - 04005.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 4 MONTHS LATER DUE TO PAIN, DIFFICULTY AMBULATING, AND TISSUE DAMAGE. THERE WAS NOTHING WRONG WITH THE SCREWS THEMSELVES, THEY WERE JUST PLACED IN A POSITION THAT WAS CAUSING SOFT TISSUE IRRITATION AND WERE, THEREFORE, REMOVED. 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
    1472109 BONE SCR 6.5X30 SELF-TAP PROSTHETIC, HIP LPH ZIMMER MANUFACTURING B.V. N/A 64707203

    Patients

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