BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 23065211 · Received September 16, 2025

    Report

    Report Number
    1818910-2025-15960
    Event Type
    Injury
    Date Received
    September 16, 2025
    Date of Event
    December 7, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    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). 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 MANUFACTURER NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.

    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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: DE LEISSEGUES T, VISTE A, FESSY MH. REVISION OF TOTAL HIP ARTHROPLASTY BY LONG LOCKING STEM WITH FULLY HYDROXYAPATITE-COATED MODULAR METAPHYSIS (REEF¿): A CONTINUOUS SERIES OF 78 CASES AT A MINIMUM 2-YEAR FOLLOW-UP. ORTHOP TRAUMATOL SURG RES. 2024 APR;110(2):103786. DOI: 10.1016/J.OTSR.2023.103786. EPUB 2023 DEC 7. PMID: 38070731. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THE STUDY WAS TO SUPPORT THE UNCEMENTED STRATEGY IN FEMORAL REVISION, WHICH IS NOT YET WIDELY USED WORLDWIDE, BY STUDYING THE REEF IMPLANT. A RETROSPECTIVE STUDY IS CONDUCTED AT MORE THAN 2 YEARS¿ FOLLOW-UP, IN A CONTINUOUS SERIES OF TOTAL HIP ARTHROPLASTY (THR) REVISION PROCEDURES USING THIS LONG FULLY-HYDROXYAPATITE-COATED MODULAR LOCKING STEM, ASSESSING 1) IMPLANT SURVIVAL, 2) CLINICAL AND FUNCTIONAL RESULTS, AND 3) RADIOGRAPHIC RESULTS AND 4) SURGERY-RELATED COMPLICATIONS (DEATH, DISLOCATION, SURGERY-SITE INFECTION) IN THE SHORT TERM (<2 MONTHS) AND AT LAST FOLLOW-UP. BETWEEN JANUARY 2007 AND DECEMBER 2018, 413 FEMORAL STEM EXCHANGES WERE PERFORMED IN OUR CENTER, A REEF¿ MODEL BEING NEEDED IN 93 CASES (59 FEMALES & 31 MALES; MEAN AGE: 76 ± 13 YEARS (RANGE, 32 ¿ 95). MEAN FOLLOW-UP WAS 6 ± 3 YEARS (RANGE, 2 ¿ 12). LOT, MODEL AND CATALOG NUMBERS ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: REEF¿ (DEPUY) FEMORAL STEM OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: ACETABULAR COMPONENT (UNKNOWN MANUFACTURER). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL CONSTRUCT REEF (QTY 47): (N=25) TRANSFUSION; BLOOD LOSS (ML) 950 ± 625 (32 ¿ 95), (N=3) ACUTE CORONARY SYNDROME; NO TREATMENT INDICATED, (N=1) PULMONARY EMBOLISM; NO TREATMENT INDICATED, (N= 9) SURGICAL SITE INFECTION; 7 PATIENTS WITH FAVORABLE PROGRESSIONS AFTER IRRIGATION AND MOBILE COMPONENT EXCHANGE AND 2 PATIENTS REQUIRING IMPLANT REMOVAL, (N=9) STRESS SHIELDING; NO TREATMENT INDICATED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL HEAD (QTY 5): (N= 5) DISLOCATION; NO TREATMENT INDICATED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL STEM REEF DISTAL STEM (QTY 5): (N=1) ASEPTIC LOOSENING INVOLVED IMPLANT FRACTURE; UNDERWENT FEMORAL REVISION. (N= 2) SEPTIC LOOSENING; REQUIRED IMPLANT REMOVAL, WITHOUT REIMPLANTATION, FOR MEDICAL REASONS. (N=1) ANTERIOR CORTICAL EFFRACTION, WITH A 375 MM STEM; NO INTERVENTION NOTED. (N=1) >5 MM SUBSIDENCE AT 6 MONTHS, INVOLVING DISTAL LOCKING DEFECT, WITH ONE SCREW PLACED OUTSIDE THE LOCKING HOLE, NOT SPOTTED INTRAOPERATIVELY; AT LAST FOLLOW-UP, THE PATIENT WAS FREE OF PAIN AND X-RAY SHOWED GOOD OSSEOINTEGRATION OF THE STEM; NO TREATMENT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2680004 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention