BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX OPTION TYPE 1 TPR SLEVE -3

    MDR report key: 22148481 · Received June 5, 2025

    Report

    Report Number
    3002806535-2025-00221
    Event Type
    Injury
    Date Received
    June 5, 2025
    Date of Event
    May 16, 2025
    Report Date
    September 23, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    K192683
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 ¿ 123952HA, EXC ABT STD SHELL HA/PC 052MM, LOT 2032967, 650-0791, BIOLOX DELTA LNR 32MM 50- 52MM, LOT 3042013, 103531, TI LOW PROFILE SCREW 6.5X20MM, LOT 772790 , 103531, TI LOW PROFILE SCREW 6.5X20MM, LOT 772790, 650-1056, CER BIOLOXD OPTION HD 32MM, LOT 3075336, 192110, ECHO POR FMRL LAT NC 10X130MM, LOT 652920. G2 ¿ FOREIGN ¿ AUSTRALIA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H5, H6, H10, H11. CORRECTED: D4 (EXPIRATION DATE) 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 IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED SLEEVE AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. REVIEW OF THE COMPLAINT HISTORIES FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THE HEAD AND THE REPORTED PART AND LOT COMBINATION. HANDWRITTEN MEDICAL RECORDS ALONG WITH A STICKER SHEET WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW IDENTIFIED THAT THE WRITING WAS ILLEGIBLE AND NOTHING COULD BE GAINED FROM THE NOTES. 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 UNDERWENT REVISION SURGERY DUE TO INSTABILITY OF THE RIGHT HIP ELEVEN YEARS POST IMPLANTATION. THE HEAD AND SLEEVE WERE EXCHANGED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762009 BIOLOX OPTION TYPE 1 TPR SLEVE -3 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LPH BIOMET UK LTD. 2924704

    Patients

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