BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER TRABECULAR METAL TOTAL ANKLE

    MDR report key: 22106768 · Received May 29, 2025

    Report

    Report Number
    0001822565-2025-01586
    Event Type
    Injury
    Date Received
    May 29, 2025
    Report Date
    June 11, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSN
    PMA / PMN Number
    NI
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 UPDATED/CORRECTED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6; H10. D10: ITEM# UNK TIBIAL COMPONENT; LOT# UNKNOWN. ITEM# UNK TALAR INSERT; LOT# UNKNOWN. ATTEMPTS HAVE BEEN MADE TO GATHER PRODUCT ID INFORMATION AND NO FURTHER INFO IS AVAILABLE. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER BIOMET ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS UNLIKELY THAT THE SPECIFIED DEVICE CAUSED ANY PATIENT INFECTION. THE REPORTED EVENT IS UNCONFIRMED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM# UNK TIBIAL COMPONENT; LOT# UNKNOWN. E1: FULL ESTABLISHMENT NAME - (B)(6) HOSPITAL. G2: FOREIGN - EVENT OCCURRED IN SPAIN. G2: LITERATURE - HERNÁNDEZ-JIMÉNEZ, P., MANCHEÑO-LOSA, M., MELÉNDEZ-CARMONA, M. Á., MELLADO-ROMERO, M. Á., BRAÑAS, P., LUMBRERAS-BERMEJO, C., VILÁ Y RICO, J. E., & LORA-TAMAYO, J. (2025). PERIPROSTHETIC INFECTION OF TRANSFIBULAR ANKLE ARTHROPLASTIES MANAGED WITH IMPLANT RETENTION: ANATOMICAL LIMITATIONS OF SURGICAL DEBRIDEMENT. ANTIBIOTICS, 14(3), 215. HTTPS://DOI.ORG/10.3390/ANTIBIOTICS14030215. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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

    IT WAS REPORTED THAT APPROXIMATELY THREE (3) WEEKS AGO, A JOURNAL ARTICLE WAS RETRIEVED FROM ANTIBIOTICS THAT REPORTED A STUDY FROM SPAIN. THE PURPOSE OF THE STUDY WAS TO ANALYZE OUR EXPERIENCE IN THE MANAGEMENT OF PROSTHETIC ANKLE INFECTIONS (PAI) BY FOCUSING ON THE PECULIARITIES OF TRANSFIBULAR APPROACH WITH SPECIAL ATTENTION TO CASES MANAGED WITH IRRIGATION AND DEBRIDEMENT LIMITED TO THE FIBULAR PLATE. THE STUDY REVIEWED A TOTAL OF 291 EPISODES OF PROSTHETIC JOINT INFECTION (PJI) AT THEIR CENTER, 10 WITH ANKLE ARTHROPLASTIES AND OF THESE 10, 7 WERE THE TRANSFIBULAR APPROACH. PROTHESES IMPLANTED VIA TRANSFIBULAR WERE TM ANKLER (ZIMMER BIOMET, WARSAW, IN). THE INDICATION FOR SURGERY WAS FOUR PATIENTS WITH POST-TRAUMATIC INJURY, TWO WITH ARTHROSIS, AND ONE WITH A CHRONIC INFLAMMATORY DISEASE. THE STUDY REPORTED ONE PATIENT HAD AN INITIAL ANKLE ARTHROPLASTY DUE TO ARTHROSIS AND SUBSEQUENTLY DEVELOPED AN S. AUREUS METHICILLIN-SUSCEPTIBLE INFECTION 77 DAYS POST TOTAL ANKLE ARTHROPLASTY. AN INCISION AND DRAINAGE WAS PERFORMED WITH OSTEOSYNTHESIS MATERIAL REMOVAL. NO ANKLE COMPONENTS WERE REVISED. ANTIBIOTIC TREATMENT PROVIDED. ON AN UNKNOWN DATE A 2 STAGE REVISION WAS COMPLETED WITH ARTHRODESIS. RADIOGRAPHS AT LAST FOLLOW UP SHOWED CONSOLIDATION AND PATIENT AMBULATING WITH 2 CRUTCHES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746402 ZIMMER TRABECULAR METAL TOTAL ANKLE PROSTHESIS, ANKLE, SEMI-CONSTRAINED HSN ZIMMER BIOMET, INC. NI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown Required Intervention| H SEE NARRATIVE IN H11.