BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M2A MAGNUM MODULAR HEAD

    MDR report key: 22852948 · Received August 20, 2025

    Report

    Report Number
    0001825034-2025-02591
    Event Type
    Malfunction
    Date Received
    August 20, 2025
    Date of Event
    November 17, 2015
    Report Date
    December 22, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K101336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT: 139266, LOT: 213450, M2A-MAGNUM 52-60MM TPR INSRT-3. G2: FOREIGN ¿ CANADA. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) ¿ HEAD. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3; H2; H3; H4; H6; H10 THE FOLLOWING SECTIONS WERE CORRECTED: B7. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE PROVIDED. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE PATIENT HAD AN INITIAL RIGHT. OPERATIVE NOTES FROM THE INITIAL SURGERY REVEAL NO COMPLICATIONS. PATIENT UNDERWENT A REVISION DUE TO UNKNOWN INDICATIONS. OPERATIVE NOTES FROM THE REVISION SURGERY REVEAL THERE WERE NO SIGNS OF INFECTION. THE HEAD COULD NOT BE DISENGAGED FROM THE FEMORAL STEM. A DECISION WAS MADE TO PROCEED WITH AN EXTENDED TROCHANTERIC OSTEOTOMY. THE HEAD AND STEM WERE THEN ABLE TO BE REMOVED WITHOUT FURTHER COMPLICATION. ACETABULAR COMPONENT WAS LOOSE AND EASILY REMOVED. A NEW SHELL, SCREWS AND LINER WERE PLACED, ALONG WITH A NEW STEM AND HEAD. GOOD STABILITY ACHIEVED, NO FURTHER COMPLICATIONS NOTED. REVIEW OF THE AVAILABLE INFORMATION INDICATES THE DEVICE WAS RELEASED IN A CONFORMING STATE, AND IS FUNCTIONING AS EXPECTED PER THE DOCUMENTED DESIGN REQUIREMENTS. NO DEVICE FAILURE WAS IDENTIFIED. COMPLAINT IS 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.

    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 DURING THE PROCEDURE, AFTER REPEATED ATTEMPTS, THE HEAD COULD NOT BE DISENGAGED FROM THE STEM. AN OSTEOTOMY (ETO) WAS USED AND THE HEAD AND STEM WERE ABLE TO BE REMOVED WITH NO FURTHER COMPLICATIONS. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151140 M2A MAGNUM MODULAR HEAD PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 955560

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male