BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL HEAD CERAMIC

    MDR report key: 24832243 · Received April 9, 2026

    Report

    Report Number
    1818910-2026-06529
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    August 20, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT/LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. 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: THE DEVICE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED.

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: LU Z, YUAN C, XU Q, FENG Y, XIA Q, WANG X, ZHU J, WU J, WANG T, CHEN J, WANG X, WANG Q. AI-ASSISTED 3D VERSUS CONVENTIONAL 2D PREOPERATIVE PLANNING IN TOTAL HIP ARTHROPLASTY FOR CROWE TYPE II-IV HIGH HIP DISLOCATION: A TWO-YEAR RETROSPECTIVE STUDY. J ORTHOP SURG RES. 2025 AUG 20;20(1):777. DOI: 10.1186/S13018-025-06208-X. PMID: 40836303; PMCID: PMC12366076. OBJECTIVE/METHODS/STUDY DATA: THIS SINGLE-CENTER RETROSPECTIVE COHORT STUDY COMPARED CLINICAL OUTCOMES OF AI-ASSISTED 3D VERSUS CONVENTIONAL TWO-DIMENSIONAL (2D) X-RAY PREOPERATIVE PLANNING IN SUCH CASES. BETWEEN MAY 2020 AND JANUARY 2023, A TOTAL OF 92 CONSECUTIVE PATIENTS WITH HHD WHO UNDERWENT THA RECEIVED EITHER AI-ASSISTED 3D PREOPERATIVE PLANNING (N = 49) OR 2D X-RAY PREOPERATIVE PLANNING (N = 43). IN BOTH GROUPS, THE PROSTHETIC COMPONENTS USED IN SURGERY INCLUDED PINNACLE ACETABULAR CUPS, ALTRX LINERS, BIOLOX FEMORAL HEADS, AND EITHER SUMMIT OR CORAIL FEMORAL STEMS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: PINNACLE ACETABULAR CUPS AND SUMMIT OR CORAIL FEMORAL STEMS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR LINER POLY AND UNK HIP FEMORAL HEAD CERAMIC (QTY 1): N=1 UNDERWENT LINER EXCHANGE AT 6 MONTHS POSTOPERATIVELY DUE TO RECURRENT DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94288 UNK HIP FEMORAL HEAD CERAMIC CERAMIC FEMORAL HEAD LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention