BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M/H SLD/APX HLE RNGLC SHL 56MM

    MDR report key: 7771143 · Received August 9, 2018

    Report

    Report Number
    0001825034-2018-08026
    Event Type
    Injury
    Date Received
    August 9, 2018
    Date of Event
    April 9, 2008
    Report Date
    October 2, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK861114
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES PROVIDED. THE PRODUCT WAS NOT RETURNED FOR THE INVESTIGATION, THEREFORE A VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY LEFT TOTAL ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAD DISTAL WOUND SEPARATION AND A SMALL AMOUNT OF SEROPURULENT MATERIAL AND STITCH ABSCESS A MONTH AFTER THE PRIMARY.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 11-363660 36MM COCR MOD HD -6MM LOT# 505940, ITEM# 15-103205 TAPERLOC MICRO LAT FMRL 11MM LOT# 402250, ITEM# EP-105914 EPOLY 36MM RINGLC LNR HW SZ24 LOT# 974060. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. 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 - 2018 - 08027, 0001825034 - 2018 - 08024, 0001825034 - 2018 - 08025.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT PRIMARY LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY 10 YEARS AGO. PATIENT EXPERIENCED DISTAL WOUND SEPARATION AND A SMALL AMOUNT OF SEROPURULENT MATERIAL ON AN UNKNOWN DATE. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612154 M/H SLD/APX HLE RNGLC SHL 56MM PROSTHESIS HIP JDI ZIMMER BIOMET, INC. N/A 569300

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other