BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A TAPER 37/28MM LINER

    MDR report key: 8508751 · Received April 12, 2019

    Report

    Report Number
    0001825034-2019-01586
    Event Type
    Injury
    Date Received
    April 12, 2019
    Report Date
    November 14, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K993438
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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. 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 MDR SUBMITTED FOR THIS REPORT: 0001825034 - 2019 - 02500.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF LAB REPORTS NOTING ELEVATED METAL ION LEVELS. ADDITIONAL INFORMATION DOES NOT CHANGE THE ROOT CAUSE OF THE PREVIOUS INVESTIGATION. 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

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 11-163664 28MM M2A MOD HEAD +6MM NK LOT# 534540; ITEM# 162314 BI-METRIC POROUS FMRL 15X155MM LOT# 680020; ITEM# 15-103660 M2A-T UNIV 2-HOLE SHL 60MM LOT# 008720. 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: 0001825034-2019-01588.

    Description of Event or Problem · 1

    IT WAS REPORTED BILATERAL PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY APPROXIMATELY 18 YEARS AGO. SUBSEQUENTLY PATIENT HAS REPORTED EXPERIENCING COBALT TOXICITY (MENTAL AND PHYSICAL), PSEUDOTUMORS, BONE LOSS, MUSCLE LOSS, AND PAIN. REVISION WILL BE SCHEDULED FOLLOWING REVISION OF HIS LEFT HIP. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301673 M2A TAPER 37/28MM LINER PROSTHESIS HIP KWA ZIMMER BIOMET, INC. N/A 011240 

    Patients

    Seq Age Sex Outcome Treatment
    1 Other