BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 52ODX46ID

    MDR report key: 23277302 · Received October 15, 2025

    Report

    Report Number
    0001825034-2025-03179
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    April 25, 2024
    Report Date
    December 30, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K101336
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE {UPDATE/CORRECTED}. UPDATED: D4; G3; H2; H3; H4; H6. 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 REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: OPERATIVE REPORT; WE OBSERVE THAT THERE IS ALREADY A DISLOCATION OF THE SMITH & NEPHEW DOUBLE MOBILITY POLYETHYLENE THAT WAS IN THE ZIMMER CUP, WHICH HAD BEEN TEMPORARILY PLACED DURING THE SURGERY AND LAVAGE. SLIGHT RETROVERSION OF THE CUP. CUP REMOVED. SMALL AREA OF OSTEOLYSIS IN THE ANTEROSUPERIOR, ANTEROPOSTERIOR, AND SLIGHTLY POSTERIOR REGIONS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED, HOWEVER THERE WAS A COMPETITOR LINER USED WITH A ZIMMER BIOMET CUP. IT'S UNKNOWN IF THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. AS PER IFU IT STATES ' BIOMET HAS EVALUATED THE COMPATIBILITY OF BIOMET DEVICES WITH IMPLANTS AND COMPONENTS FROM ZIMMER ORTHOPEDIC COMPANIES. ONLY AUTHORIZED COMBINATIONS SHOULD BE USED. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. 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: UNK S&N DUAL MOBILITY LINER. UNK HEAD 28MM. UNK -6 TAPER ADAPTER. CAT# 103201 LOT# 948990 TAPERLOC POR FMRL 6.0X132. G2: FOREIGN: CANADA. 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 AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY FOLLOWED BY AN EMERGENT SURGERY APPROXIMATELY 14 YEARS LATER DUE TO SEPSIS WITH METAL RELATED PATHOLOGY. AS THIS WAS AN EMERGENT SURGERY FOR STABILIZATION, THE SURGEON HAD PLANNED FOR A REPEAT STAGE I SURGERY FOR A MORE EXTENSIVE DEBRIDEMENT WITH CUP REVISION WITH THE PATIENT¿S PRIMARY SURGEON AND PLACEMENT OF FINAL IMPLANTS. SUBSEQUENTLY, 3 DAYS POST EMERGENT SURGERY, THE PATIENT UNDERWENT THE REPEAT STAGE I REVISION WHERE THE JOINT WAS FURTHER DEBRIDED, OSTEOLYSIS WAS FOUND SURROUNDING THE CUP, AND THE COMPETITOR LINER WAS FOUND DISLOCATED FROM THE ZIMMER CUP. AFTER ADMINISTRATION OF THREE MONTHS OF ANTIBIOTICS, THE PATIENT DISPLAYED NO SIGNS OF INFECTION AND UNDERWENT THE STAGE II REVISION APPROXIMATELY 4 MONTHS LATER. A SMALL SEROMA WAS FOUND LATERALLY AND DRAINED AND FINAL IMPLANTS WERE PLACED WITHOUT COMPLICATION ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178608 M2A-MAGNUM PF CUP 52ODX46ID PROTHESIS, HIP LPH ZIMMER BIOMET, INC. 099730

    Patients

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