BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38 MM ONE-PIECE CUP

    MDR report key: 21592692 · Received March 13, 2025

    Report

    Report Number
    0001825034-2025-00690
    Event Type
    Injury
    Date Received
    March 13, 2025
    Date of Event
    November 14, 2023
    Report Date
    May 9, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. THE FOLLOWING SECTIONS WERE UPDATED: D4; G3; H2; H3; H4; H6; H10 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. MEDICAL RECORDS WERE PROVIDED AND REVIEW IDENTIFIED THE FOLLOWING: TURBID BROWN, DARK TEA-COLORED FLUID ENCOUNTERED, CONSISTENT WITH ARMD. THERE WAS SOME BUT REALLY NOT A SIGNIFICANT AMOUNT OF CORROSION MATERIAL AROUND THE INNER BORE OF THE FEMORAL HEAD. THE TRUNNION ON THE FEMORAL STEM LOOKED PRISTINE WITHOUT ANY DAMAGE. NECROTIC TISSUE REMOVED FROM AROUND THE SOCKET, PSEUDOCAPSULE EXCISED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT CAN BE CONFIRMED. 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: 21-123209, LOT: 909060 HA TPRLOC POR LAT FML 17.5X155. H6: SUGGESTED COMPONENT CODE: MECHANICAL (G04), HEAD. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. 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 20 YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO METAL RELATED PATHOLOGY. DURING THE REVISION, CORROSION MATERIAL WAS NOTED AROUND THE INNER BORE OF THE FEMORAL HEAD. A PSEUDOCAPSULE, NECROTIC TISSUE, AND A CYST WAS DEBRIDED, WHICH THE SURGEON ATTRIBUTED TO ADVERSE REACTION TO METAL DEBRIS. THE HEAD WAS REPLACED. THE STEM AND CUP WERE RETAINED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917166 M2A 38 MM ONE-PIECE CUP PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. 395770

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H11 NARRATIVE.