BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM M2A HI CARBON HD STD NK

    MDR report key: 7835873 · Received August 30, 2018

    Report

    Report Number
    0001825034-2018-08588
    Event Type
    Injury
    Date Received
    August 30, 2018
    Date of Event
    July 5, 2018
    Report Date
    September 27, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK993438
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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: ITEM# 15-103650, M2A-T UNIV 2-HOLE SHL 50MM, LOT# 083410; ITEM# 15-105011, M2A TPR HI CARBON 37/28MM LNR, LOT# 981570. FOREIGN SOURCE: (B)(6). 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 08589.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY APPROXIMATELY 7 YEARS AGO. MRI PERFORMED 4 YEARS POST OP SHOWED CYSTS LESION LOCATED ON INGUINAL PART. SUBSEQUENTLY, PATIENT WAS REVISED 7 YEARS POST IMPLANTATION. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674436 28MM M2A HI CARBON HD STD NK PROSTHESIS HIP KWA ZIMMER BIOMET, INC. N/A 993010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R