BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNK CUP

    MDR report key: 23052220 · Received September 15, 2025

    Report

    Report Number
    0001822565-2025-03397
    Event Type
    Injury
    Date Received
    September 15, 2025
    Report Date
    April 21, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: UNK CERAMTEC BIOLOX HEAD. G2: FOREIGN ¿ SOUTH KOREA. JOURNAL CITATION: DO, M.U., SEO, J-S., KANG, S.W., KOO, H.T., SUH, K.T., AND SHIN, W.C. (2025). TOTAL HIP ARTHROPLASTY USING DUAL MOBILITY CUPS FOR FAILED HIP FRACTURE FIXATION. CLINICS IN ORTHOPEDIC SURGERY 17(4), 575-581. HTTPS://DOI.ORG/10.4055/CIOS24372. 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; H6. D4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. CERAMTEC IS LISTED AS THE MANUFACTURER OF THE HEAD WHICH WOULD BE CONSIDERED OFF-LABEL. HOWEVER, CERAMTEC IS A SUPPLIER OF BIOLOX HEADS THEREFORE THE HEAD CANNOT BE RULED OUT AS A ZIMMER BIOMET COMPONENT. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THREE PATIENTS EXPERIENCED DEEP JOINT INFECTION POST HIP PROCEDURE ON AN UNKNOWN DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142495 UNK CUP PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other