BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL HEAD CERAMIC

    MDR report key: 24832719 · Received April 9, 2026

    Report

    Report Number
    1818910-2026-06533
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    December 4, 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. 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. 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. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: LU Z, WANG Q, WANG X, XU Q, FENG Y, CHEN J, WANG X, ZHU J, WU J, WANG T, XIA Q, FAN X, YUAN C. SEVERITY-DEPENDENT BENEFITS OF AI-ASSISTED 3D PLANNING IN TOTAL HIP ARTHROPLASTY: A CROWE I-IV SUBGROUP AND TREND ANALYSIS. BMC MUSCULOSKELET DISORD. 2025 DEC 4;26(1):1087. DOI: 10.1186/S12891-025-09348-7. PMID: 41345606; PMCID: PMC12676770. OBJECTIVE/METHODS/STUDY DATA: THIS STUDY AIMS TO COMPARE AI-ASSISTED 3D (AI-3D) PREOPERATIVE PLANNING VERSUS TWO-DIMENSIONAL (2D) X-RAY PREOPERATIVE PLANNING FOR TOTAL HIP ARTHROPLASTY (THA) USING SUBGROUP ANALYSES (CROWE I¿II VS. III¿IV), AND TO EXAMINE ASSOCIATIONS BETWEEN DEFORMITY SEVERITY AND BOTH PLANNING ACCURACY AND CLINICAL OUTCOMES VIA ORDERED TREND ANALYSES. BETWEEN MAY 2020¿JULY 2023, A TOTAL OF 116 CONSECUTIVE PATIENTS UNDERWENT THA (AI-3D N = 61; 2D X-RAY N = 55) USING CEMENTLESS IMPLANT SYSTEM FROM THE SAME FAMILY IN ALL CASES (PINNACLE ACETABULAR SYSTEM WITH ALTRX LINER, BIOLOX FEMORAL HEAD, AND SUMMIT/CORAIL FEMORAL STEM). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: PINNACLE ACETABULAR SYSTEM AND SUMMIT/CORAIL FEMORAL STEM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR CONSTRUCT PINNACLE (QTY 1): N=1 PERIPROSTHETIC JOINT INFECTION AT 1 MONTH POSTOPERATIVELY - UNDERWENT DAIR (DEBRIDEMENT, ANTIBIOTICS, AND IMPLANT RETENTION) WITH POLYETHYLENE LINER EXCHANGE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL HEAD CERAMIC AND UNK HIP ACETABULAR LINER POLY (QTY 1): N=1 REQUIRED POLYETHYLENE LINER REVISION AT 6 MONTHS FOR RECURRENT DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93804 UNK HIP FEMORAL HEAD CERAMIC CERAMIC FEMORAL HEAD LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention