BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 24130416 · Received January 21, 2026

    Report

    Report Number
    1818910-2026-01214
    Event Type
    Injury
    Date Received
    January 21, 2026
    Date of Event
    September 2, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. H11 ADDITIONAL NARRATIVE: ADDED: D10 (CONCOMITANT).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: JØRGENSEN PB, HOMILIUS M, KOPPENS D, HANSEN TB, STILLING M. SIMILAR FEMORAL STEM FIXATION BUT LESS METAPHYSEAL LOSS OF BONE MINERAL DENSITY WITH A TAPER-WEDGE DESIGN AND DIAPHYSEAL BONE PRESERVATION WITH A LONG AND ROUND-TAPERED DESIGN: A 5-YEAR RANDOMIZED RSA AND DXA STUDY OF 50 PATIENTS. ACTA ORTHOP. 2025 SEP 2;96:656-663. DOI: 10.2340/17453674.2025.43907. PMID: 40891927; PMCID: PMC12404101. OBJECTIVE/METHODS/STUDY DATA: THE PRIMARY AIM WAS TO COMPARE FEMORAL STEM FIXATION (SUBSIDENCE) OF THE NEWER METAPHYSEAL ULTRA-POROUS-COATED TAPER-WEDGE TRI-LOCK STEM WITH THE CLASSIC METAPHYSEAL POROUS-COATED LONGER ROUND-TAPERED SUMMIT STEM, AND SECONDARILY TO COMPARE THE CHANGE IN PERIPROSTHETIC BONE MINERAL DENSITY (BMD) AND PATIENT-REPORTED OUTCOME MEASURES (PROMS) BETWEEN STEM GROUPS. BETWEEN JANUARY 2015 AND AUGUST 2017, INCLUDED PATIENTS WERE: INCLUSION CRITERIA WERE: (I) PRIMARY HIP OSTEOARTHRITIS, (II) SUFFICIENT BONE QUALITY FOR CEMENTLESS IMPLANTS, ASSESSED BY THE SURGEON, AND (III) AGE BETWEEN 40 AND 70 YEARS. PATIENTS WERE BLOCK RANDOMIZED IN BLOCKS OF 10 TO THE TRI-LOCK (N = 26) OR THE SUMMIT (N = 26) FEMORAL STEM GROUP. ALL PATIENTS RECEIVED A CEMENTLESS POROUS COATED TITANIUM PINNACLE CUP (DEPUY ORTHOPEDICS, INC, WARSAW, IN, USA), A CROSS-LINKED POLYETHYLENE LINER (MARATHON, DEPUY ORTHOPE DICS, INC, WARSAW, IN, USA), AND A 32 MM OR 36 MM COCR FEMORAL HEAD (DEPUY ORTHOPEDICS, INC, WARSAW, IN, USA). STEREORADIOGRAPHS, PERIPROSTHETIC BMD, AND PATIENT-REPORTED OUTCOME MEASURES WERE FURTHER COLLECTED AT 3-MONTH, 1-, 2-, AND 5-YEAR FOLLOW-UP. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES TRI-LOCK STEM, SUMMIT STEM, MARATHON POLYETHYLENE LINER, DEPUY UNK FEMORAL HEAD OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: DEPUY PINNACLE CUP ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL CONSTRUCT TRI-LOCK (QTY 2): (N=1) PERIPROSTHETIC FRACTURE WHICH WAS DISCOVERED ON RADIOGRAPHS AT 3-MONTH FOLLOW-UP AND TREATED CONSERVATIVELY. (N=1) DEEP PROSTHETIC JOINT INFECTION, WHICH WAS TREATED WITH ONE-STAGE REVISION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL STEM TRI-LOCK (QTY 6): - (N=3) CONTINUOUS SUBSIDENCE OR RETROVERSION AFTER 2-YEAR FOLLOW-UP BEYOND THE LIMIT OF AGREEMENT WAS DETECTED. - (N=1) AT THE 5-YEAR FOLLOW-UP, THE TRI-LOCK STEMS HAD SUBSIDENCE OF 0.38 MM (CI 0.04¿0.72) AND RETROVERSION OF 1.68° (CI 0.80¿2.55). - (N=2) ROTATED MORE THAN ¿2° AROUND THE Z-AXES INTO VARUS BEFORE THE 3-MONTH FOLLOW-UP AND STABILIZED THEREAFTER. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL STEM SUMMIT (QTY 9): - (N=8) CONTINUOUS SUBSIDENCE OR RETROVERSION AFTER 2-YEAR FOLLOW-UP BEYOND THE LIMIT OF AGREEMENT WAS DETECTED. - (N=1) THE SUMMIT STEMS HAD SUBSIDENCE OF 0.24 MM (CI 0.09¿0.57) AND RETROVERSION OF 1.53° (CI 0.68¿2.37). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL HEAD & UNK HIP ACETABULAR LINERS (QTY 1): - HIP DISLOCATION AT 3-MONTH FOLLOW-UP, WHICH WAS REDUCED CLOSED AND THE PATIENT REMAINED IN THE COHORT FOR ALL DATA ANALYSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190086 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention UNK HIP ACETABULAR CUP PINNACLE.