BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA CER LNR 32MM E

    MDR report key: 22990029 · Received September 8, 2025

    Report

    Report Number
    3002806535-2025-00441
    Event Type
    Injury
    Date Received
    September 8, 2025
    Date of Event
    August 18, 2024
    Report Date
    February 26, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    UDI-DI
    05019279494583
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). D10: BIOLOX DELTA CER FEM HD 32/-3MM T1; ITEM# 650-1163; LOT# 2015021207. ECHO POR FMRL NC 11X135MM; ITEM# 192011; LOT# 506890. G7 PPS LTD ACET SHELL 52E; ITEM# 010000663; LOT# 3352906. G2 ¿ FOREIGN ¿ DENMARK. G4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K190660 INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORIES FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THESE ITEMS AND THE REPORTED PART AND LOT COMBINATIONS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT ATTENDED THE ER DUE TO PAIN. LUXATION WAS CONFIRMED, AND CLOSED REPOSITIONING WAS PERFORMED APPROXIMATELY 7 YEARS, 10 MONTHS, AND 6 DAYS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE, AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2406956 BIOLOX DELTA CER LNR 32MM E PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH BIOMET UK LTD. 3597856 05019279494583

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| O SEE H11 NARRATIVE