BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOLOX DELTA CER LNR 36MM F

    MDR report key: 21384451 · Received February 14, 2025

    Report

    Report Number
    3002806535-2025-00028
    Event Type
    Malfunction
    Date Received
    February 14, 2025
    Date of Event
    January 14, 2025
    Report Date
    July 17, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - ASSOCIATED MEDICAL DEVICES: G7 PPS LTD ACET SHELL 54F; ITEM# 010000664; LOT# 7666563, DELTA CERAMIC FEM HD 36/0MM; ITEM# 650-0661; LOT# 3197549, TPRLC 133 T1 PPS SO 10X140MM; ITEM# 51-103100; LOT# 7617285, TRILOGY BONE SCR 6.5X30; ITEM# 00-6250-065-30; LOT# 66723016, TRILOGY BONE SCR 6.5X25; ITEM# 00-6250-065-25; LOT# 66068515. G2 - FOREIGN: CHINA. 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 CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, D9, G1-2, G3, G4, G6, H2, H3, H6, H11. THE FOLLOWING SECTIONS WERE CORRECTED: G1-2. D4 - THIS PRODUCT IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). 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. PRODUCT WAS RETURNED AND VISUAL REVIEW OF THE RETURNED CERAMIC LINER CONFIRMS THE DEVICE TO BE FRACTURED. TWO MAIN PIECES WERE RETURNED. NOT ALL FRAGMENT PIECES WERE RETURNED. DARK MARKS ARE NOTED TO THE CERAMIC FROM POSSIBLE METAL TRANSFER. NO OTHER DAMAGE WAS NOTED. IMAGES OF THE RETURNED LINER WAS SENT FOR FURTHER ANALYSIS WHICH CONCLUDED THAT THEY SHOW METAL TRANSFER MARKS, LIKELY FROM CONTACT WITH THE ACETABULAR SHELL AND FROM CONTACT WITH INSTRUMENTS DURING REMOVAL. THE ROOT CAUSE OF THE LINER FRACTURE COULD NOT BE DETERMINED IN THIS INSTANCE. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS. BASED ON THE AVAILABLE INFORMATION, 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 DURING A PROCEDURE, THE LINER FAILED TO BE IMPLANTED PROPERLY. THE LINER WAS THEN FOUND TO BE BROKEN EVEN THOUGH THE SURGEON CLAIMS TO HAVE STRICTLY FOLLOWED THE SURGICAL TECHNIQUE AND UTILIZED APPROPRIATE FORCE. THERE WERE NO REPORTED HEALTH CONSEQUENCES OR IMPACTS TO THE PATIENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    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
    1638323 BIOLOX DELTA CER LNR 36MM F HIP PROSTHESIS LZO BIOMET UK LTD. 3156800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male SEE H11 NARRATIVE.