BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINN MAR NEUT 36IDX56OD

    MDR report key: 24378992 · Received February 18, 2026

    Report

    Report Number
    1818910-2026-03223
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    July 29, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295014461
    PMA / PMN Number
    K010171
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). THIS REPORT IS BEING SUBMITTED PU. SUANT 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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE COMPLAINT UNIT WAS FORWARDED TO THE DEPUY SYNTHES MATERIAL SCIENCE LAB IN WARSAW FOR FURTHER EVALUATION. VISUAL INSPECTION REVELED THAT PINN MAR NEUT 36IDX56OD SHOWS WEAR AT THE OUTER AND INNER RIM SECTION. NO OTHER ANOMALIES WERE NOTED. WITH THE INFORMATION PROVIDED IS NOT POSSIBLE TO DETERMINE A POTENTIAL CAUSE AT THIS MOMENT. THE MODE OF FAILURE OF THE DEVICE IS MULTI-FACTORIAL AND CONSIDERATION MUST BE GIVEN TO ALL OTHER POTENTIAL INFLUENCES SUCH AS SURGICAL PROCESS, PATIENT VARIABLES (E.G. ACTIVITY LEVEL AND USE), ANATOMICAL CONSIDERATIONS AND PATIENT CHANGES OVER TIME. ANY CONCLUSIONS FROM THE INVESTIGATIONAL INPUT PROVIDED HAVE TO BE PLACED INTO CONTEXT WITH ALL OTHER RELEVANT FACTORS. A FUNCTIONAL TEST WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 4240182 NUMBER, AND NO NON-CONFORMANCE'S / MANUFACTURING IRREGULARITIES RELATED TO THE COMPLAINT CONDITION WERE IDENTIFIED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE PINN MAR NEUT 36IDX56OD WOULD HAVE CONTRIBUTED TO A DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY: 1) QUANTITY MANUFACTURED: (B)(4) 2) DATE OF MANUFACTURE: 04-AUG-2023, 4) EXPIRY DATE: 31- JULY-2028, 5) IFU REFERENCE: IFU 090200701. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 4240182 NUMBER, AND NO NON-CONFORMANCE'S / MANUFACTURING IRREGULARITIES RELATED TO THE COMPLAINT CONDITION WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONE OF A CEMENTLESS HIP PROSTHESIS FRACTURED. HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2023. IT IS UNKNOWN WHEN THE REVISION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442996 PINN MAR NEUT 36IDX56OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS LPH DEPUY ORTHOPAEDICS INC US 4240182 10603295014461

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male