BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM 28MM RNGLOC LNR HWALL 22

    MDR report key: 7032724 · Received November 15, 2017

    Report

    Report Number
    0001825034-2017-10215
    Event Type
    Injury
    Date Received
    November 15, 2017
    Date of Event
    October 16, 2017
    Report Date
    November 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK926107
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. LOT NUMBER FOR THE LINER WAS REPORTED AS BEING EITHER 243260 OR 986240 IT WAS UNABLE TO BE DISTINGUISHED WHICH LOT NUMBER WAS INVOLVED IN THIS CASE. UDI: (B)(4). ITEM NAME: ARCOM 28MM RNGLOC LNR HWALL 22. CATALOG NUMBER: 11-105902. LOT NUMBER: 986240. EXPIRATION DATE: FEB 22, 2022. MANUFACTURE DATE: FEB 22, 2017. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. INSPECTION OF THE RETURNED DEVICE REVEALED THE RIM TO BE SCRATCHED AND SCUFFED, WHICH PROBABLY CAUSED DURING EXTRACTION. A DIMPLE WAS OBSERVED ON THE INNER RADIUS THAT IS CONSISTENT WITH THE SCREW HOLE IN THE LINER. THE SQUARE ORIENTATION FEATURE AT THE APEX OF THE SHELL'S INNER RADIUS EXHIBITS EVIDENCE OF THE INSERTER NOT BEING ALIGNED WELL WITH THAT FEATURE DURING IMPACTION. DIMENSIONAL ANALYSIS FOUND THE INSIDE SPHERICAL RADIUS AND RADIUS LOCATION OF THE SHELL TO BE WITHIN SPECIFICATION. THE DIMENSIONAL ANALYSIS OF THE RING CONFIRMED THE WIDTH AND HEIGHT TO BE WITHIN MANUFACTURING SPECIFICATIONS DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO 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: 14-103648, UNIV 2-HOLE SHL 48MM LNR SZ 22, 684210. REPORT SOURCE, FOREIGN ¿ EVENTS OCCURRED IN .B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 - 2017 - 10216.

    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 THE LINER WOULD NOT SEAT PROPERLY, AND THE SURGEON WAS UNABLE TO REMOVE IT FROM THE CUP. THEREFORE, BOTH THE CUP AND THE LINER HAD TO BE REMOVED. THE PROCEDURE WAS DELAYED FOR 60 MINUTES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814287 ARCOM 28MM RNGLOC LNR HWALL 22 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 243260

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R