BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7

    MDR report key: 23786000 · Received December 11, 2025

    Report

    Report Number
    0001825034-2025-03960
    Event Type
    Injury
    Date Received
    December 11, 2025
    Date of Event
    November 17, 2025
    Report Date
    April 24, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304526778
    PMA / PMN Number
    K121874
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) D10: CAT: 650-0662 LOT: 3062846 DELTA CERAMIC FEM HD 36/+3MM. G2: FOREIGN ¿ SPAIN. 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: A1; A2; B5; B7; G3; H2; H6 CLINICAL AND DEVICE CODES 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; H6. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE EXPLANTED DEVICE, BIO-DEBRIS PRESENT. THE LINER SHOW SIGNS OF WEAR, NO FRACTURE CAN BE IDENTIFIED BASED ON THE IMAGE PROVIDED. DEVICE NOT RETURNED, FURTHER ANALYSIS CANNOT BE MADE. REVIEW OF THE DEVICE HISTORY RECORD 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: PAIN, INITIALLY REPORTS THEY HAD SUFFERED A FALL WITH THE BIKE, LATER DENIES IT. ¿RADIOLOGY SHOWED FINDINGS COMPATIBLE WITH FRACTURE OF THE RIGHT CERAMIC HEAD.¿ REVISION: FRACTURE OF CERAMIC HEAD, BROKEN IN HALF, FREE FRAGMENTS; FRACTURE OF THE INNER POLYETHYLENE LINER, POSTERIOR PART INTACT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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

    IT WAS REPORTED THAT APPROXIMATELY FOUR YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO A HEAD FRACTURE SUSPECTED WITH RADIOGRAPHS FOLLOWING A FALL FROM A BICYCLE. DURING SURGERY, THE HEAD WAS FOUND FRACTURED AND THE LINER WAS FOUND TO BE DETERIORATED FROM ABRASION WITH THE HEAD FRAGMENTS. HEAD FRAGMENTS WERE REMOVED AND A NEW LINER AND HEAD WERE PLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY FOUR YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO A HEAD FRACTURE SUSPECTED WITH RADIOGRAPHS FOLLOWING A FALL FROM A BICYCLE AND EXPERIENCED PAIN. DURING SURGERY, THE HEAD WAS FOUND FRACTURED AND THE LINER WAS FOUND TO BE DETERIORATED AND FRACTURED FROM ABRASION WITH THE HEAD FRAGMENTS. HEAD FRAGMENTS WERE REMOVED AND A NEW LINER AND HEAD WERE PLACED. 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
    2710317 G7 PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. 6962506 00880304526778

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R