BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP BA BIO 28MM 12/14 + 8.5

    MDR report key: 21883956 · Received April 22, 2025

    Report

    Report Number
    1818910-2025-06166
    Event Type
    Injury
    Date Received
    April 22, 2025
    Date of Event
    January 7, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295359135
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A SEARCH OF THE J&J MEDTECH ORTHOPAEDICS NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT 9111123/LOT 4165118 COMBINATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: A SEARCH OF THE J&J MEDTECH ORTHOPAEDICS NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC'S ASSOCIATED WITH THIS PRODUCT 9111123/LOT 4165118 COMBINATION. H11 ADDITIONAL NARRATIVE: CORRECTED: D4 (PRIMARY UDI NUMBER).

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY ORTHOPAEDICS IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY ORTHOPAEDICS HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY ORTHOPAEDICS OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY ORTHOPAEDICS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: D4/G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THEREFORE, (01) GTIN IS NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A RUPTURE OF THE CERAMIC HEAD FOLLOWING A FALL. THERE WAS NOTHING NOTICED AT THIS TIME, AND THE PATIENT DID HIS GYM SESSION. THE PATIENT HAD CRACKLES IN THE NIGHT. THEN APPEARANCE OF PAIN. TOTAL HIP REPLACEMENT WAS PERFORMED ON (B)(6) 2025 IN THE ORTHOPEDIC BLOCK. THE ANALYSIS OF THE CERAMIC HEAD SHOWED A HEAD THAT HAS WORKED CONCENTRICALLY ON THE CONE. POST-OPERATIVE PROFILE CHECK SHOWED A WELL-ALIGNED HEAD. THIS WAS CONFIRMED BY THE ANALYSIS OF THE PART. THE HEAD WORKED SYMMETRICALLY AND NOT INAPPROPRIATELY. UNDER THESE CONDITIONS, IT CAN BE CONSIDERED THAT THE IMPACTION OF THE HEAD WAS NORMAL AROUND THIS MORSE CONE. THIS THEREFORE FAVORS THE FALL AS BEING AT THE ORIGIN OF THE FRACTURE OF THIS STRONG BIOLOX HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1291682 HIP BA BIO 28MM 12/14 + 8.5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS LPH DEPUY ORTHOPAEDICS INC US 4165118 10603295359135

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention