BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP NON FLARED SZ 50MM

    MDR report key: 18787764 · Received February 27, 2024

    Report

    Report Number
    0001825034-2024-00533
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    November 7, 2022
    Report Date
    June 11, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE PROVIDED AND REVIEW IDENTIFIED THE FOLLOWING: THE PATIENT UNDERWENT A LEFT THA. THE PATIENT DEVELOPED ELEVATED METAL IONS AND UNDERWENT A REVISION. DURING THE REVISION, FLUID WAS FOUND WITHIN THE JOINT FROM THE METAL ON METAL REACTION. WEAR WAS NOTED. THE HEAD WAS EXPLANTED AND REPLACED WITH ZB PRODUCTS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT WAS CONFIRMED BASED ON THE PROVIDED MEDICAL RECORDS. 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 · 0

    (B)(4). D10: CAT# 11-103203 LOT# 230220 TAPERLOC POR LAT FMRL 9X137. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2024 - 00532. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY THIRTEEN YEARS POST-IMPLANTATION, THE PATIENT HAD A LEFT HIP REVISION DUE TO ELEVATED METAL ION LEVELS AND CONCERN FOR METAL ON METAL WEAR. DURING THE PROCEDURE, THE PATIENT HAD A GOOD DEAL OF SEROSANGUINEOUS FLUID IN THE JOINT AND METAL PATHOLOGY WAS NOTED. A NEW BIPOLAR HEAD WAS PLACED. THE STEM AND CUP REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110020 M2A-38 CUP NON FLARED SZ 50MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 206140

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H10 NARRATIVE