BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM 28MM RNGLOC LNR HWALL 23

    MDR report key: 7148590 · Received December 27, 2017

    Report

    Report Number
    0001825034-2017-11298
    Event Type
    Injury
    Date Received
    December 27, 2017
    Date of Event
    December 12, 2017
    Report Date
    January 30, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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 PRODUCTS: 163660 28MM DIA COCR MOD HD -6MM NK, LOT 223630. 108253 M/H MOD 80% POR BWD DST 13X220, LOT 455220. 108110 ML-HD MOD CALC PROX 34A LOT, 353070. 120002 COCR TROCH CABLE 2.0MMX750MM, LOT 796320. 106052 RAN/BUR RNGLC SHL 52MM SZ 23, LOT 551040. 120007 COCR TROCH GRIP 2.0MM/MEDIUM, LOT 053100. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A REVISION PROCEDURE EIGHTEEN YEARS POST-IMPLANTATION DUE TO WEAR. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927976 ARCOM 28MM RNGLOC LNR HWALL 23 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 289460

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R