BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL HEAD CERAMIC

    MDR report key: 22235313 · Received June 17, 2025

    Report

    Report Number
    1818910-2025-09894
    Event Type
    Injury
    Date Received
    June 17, 2025
    Date of Event
    October 16, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. H3, H6: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KO YS, KANG SY, KIM HS, PARK JW, LEE YK, YOO JJ. INCIDENCE OF CERAMIC COMPONENT FRACTURES IN TOTAL HIP ARTHROPLASTY USING CONTEMPORARY CERAMIC-ON-CERAMIC BEARINGS: A RETROSPECTIVE STUDY SPANNING TWO DECADES FROM TWO TERTIARY REFERRAL HOSPITALS. J ARTHROPLASTY. 2025 APR;40(4):1055-1061.E3. DOI: 10.1016/J.ARTH.2024.10.023. EPUB 2024 OCT 16. PMID: 39424238. OBJECTIVE/METHODS/STUDY DATA: THE PRIMARY OBJECTIVE OF THIS RETROSPECTIVE LONGITUDINAL STUDY WAS TO DOCUMENT THE INCIDENCE OF FRACTURES IN THIRD- AND FOURTH-GENERATION COC BEARINGS OVER TWO DECADES FROM TWO TERTIARY REFERRAL HOSPITALS. THE SECONDARY OBJECTIVES OF THIS STUDY WERE TO IDENTIFY RISK FACTORS ASSOCIATED WITH CERAMIC COMPONENT FRACTURES. BETWEEN NOVEMBER 1, 1997, TO DECEMBER 31, 2022, A TOTAL OF 9,280 COC THAS OF 7,665 PATIENTS (3,748 MALE AND 3,917 FEMALE) WERE INCLUDED IN THE STUDY. THEIR MEAN AGE AT THE TIME OF THE INDEX OPERATION WAS 54 YEARS (RANGE, 16 TO 89). CERAMIC COMPONENTS USED IN THIS STUDY WERE THIRD-GENERATION ALUMINA COC BEARING (BIOLOX FORTE; CERAMTEC) IN 2,626 (28.3%) HIPS AND FOURTH-GENERATION AMC COC BEARING (BIOLOX DELTA; CERAMTEC) IN 6,654 (71.7%) HIPS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES PINNACLE CERAMIC LINER AND AML CERAMIC FEMORAL HEAD ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR LINER CERAMIC PINNACLE (QTY 1): PATIENT NO. 1: A 34.1-YEAR-OLD MAN, HAD 4TH CERAMIC LINER FRACTURE OCCURRED AT 0.1 YEAR; UNDERWENT REOPERATION (4TH CERAMIC-ON-CERAMIC EXCHANGE). PATIENT NO. 2: A 45.5-YEAR-OLD MAN, HAD 4TH CERAMIC LINER FRACTURE OCCURRED AT 0.7 YEAR; UNDERWENT REOPERATION (4TH CERAMIC-ON-POLYETHYLENE EXCHANGE). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL HEAD CERAMIC (QTY 1): PATIENT NO. 5: A 22.5-YEAR-OLD WOMAN, HAD 3RD CERAMIC HEAD FRACTURE OCCURRED AT 2.9 YEARS; UNDERWENT REOPERATION (MOPE CHANGE). PATIENT NO. 25: A 66.2-YEAR-OLD MAN, HAD 3RD CERAMIC HEAD FRACTURE OCCURRED AT 15.8 YEARS; UNDERWENT REOPERATION (4TH COC CHANGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447656 UNK HIP FEMORAL HEAD CERAMIC CERAMIC FEMORAL HEAD LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female Required Intervention