BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARCOMXL 36MM RLC LNR HW SZ25

    MDR report key: 7763127 · Received August 8, 2018

    Report

    Report Number
    0001825034-2018-06940
    Event Type
    Death
    Date Received
    August 8, 2018
    Date of Event
    December 3, 2007
    Report Date
    September 17, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK042051
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ITEM # UNKNOWN. UNKNOWN CUP LOT # UNKNOWN. ITEM # 157448 M2A-MAGNUM MOD HD SZ 48MM LOT # UNKNOWN. ITEM # UNKNOWN. UNKNOWN STEM LOT # UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 0001825034 - 2018 - 06942; 0001825034 - 2018 - 06932; 0001825034 - 2018 - 06925.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED. CONCOMITANT MEDICAL PRODUCTS: ML-HD MOD CALC PROX 34B, PART: 108112, LOT: 940540; R/H M/H 13X220 80%(165) DISTAL PART: 11-108253 LOT 232980; 36MM COCR MOD HD STD, PART: 11-363662 LOT 096120; M/H 3HOLE RLC SHL NRS 58MM/L25, PART: 13-104158 LOT 081530; COCR CABLE SLEEVE 2.0MM, PART: 120005, LOT:107130; COCR CABLE SLEEVE 2.0MM, PART: 120005 ,LOT: 777870; COCR TROCH CABLE 2.0MMX750MM, PART: 120002, LOT: 857330; COCR TROCH CABLE 2.0MMX750MM, PART: 120002, LOT: 107110. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-06925-1, 0001825034-2018-06942-1, 0001825034-2018-06932-1 , 0001825034-2018-06940-1, 0001825034-2018-08983, 0001825034-2018-08984, 0001825034-2018-08985, 0001825034 -2018-08986, 0001825034-2018-08987, 0001825034-2018-08988, 0001825034-2018-08989, 0001825034-2018-08991, 0001825034-2018-08992. 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 · 1

    IT WAS REPORTED A PATIENT UNDERWENT INITIAL RIGHT TOTAL HIP ARTHROPLASTY APPROXIMATELY 11 YEARS AGO. THE PATIENT EXPIRED DUE TO GASTROINTESTINAL HEMORRHAGE APPROXIMATELY 4 MONTHS POST IMPLANTATION. NO FURTHER INFORMATION CONCERNING THE TIMELINE OF EVENTS BETWEEN HIP ARTHROPLASTY AND PATIENT DEATH HAS BEEN PROVIDED. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604290 ARCOMXL 36MM RLC LNR HW SZ25 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 054370

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death| H| O| R .