BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY TRIT HEMI CLUSTER HOLE CUP 56MM

    MDR report key: 22874706 · Received August 22, 2025

    Report

    Report Number
    0002249697-2025-00911
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    July 29, 2025
    Report Date
    December 4, 2025
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    07613327040166
    PMA / PMN Number
    K143085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING APPEARANCE INVOLVING A TRIATHLON FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -PRODUCT EVALUATION AND RESULTS: THE DEVICE WAS RECEIVED INTO DECONTAMINATION AND TRANSFERRED TO QUALITY AND ENGINEERING. DURING ENGINEERING ANALYSIS OF THE COMPLAINT, A SURFACE SPOT WAS OBSERVED ON THE IMPLANT. GIVEN THAT THE DEVICE REMAINED UNCLEANED FOR APPROXIMATELY ONE MONTH PRIOR TO DECONTAMINATION, THE SPOT WAS HYPOTHESIZED TO BE CONSISTENT WITH BACTERIAL OR FUNGAL GROWTH RATHER THAN A MANUFACTURING DEFECT. AN ADDITIONAL CLEANING CYCLE CONFIRMED THAT EMBEDDED GROWTH PERSISTED WITHIN THE POROUS COATING. IMPORTANTLY, PHOTOGRAPHIC EVIDENCE DEMONSTRATED THAT THIS SURFACE MARKING WAS NOT PRESENT AT THE TIME OF SURGERY OR IN THE IMMEDIATE AFTERMATH OF THE COMPLAINT. -CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE THE REPORTED DEVICE WAS MANUFACTURED WITH NO REPORTED RELEVANT DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: AS PER MEMO PROVIDED BY THE GLOBAL QUALITY & OPERATIONS (GQO) TEAM STATED: BASED ON THIS INVESTIGATION, THE IMPLANT¿S GEOMETRY, COATING AND SPHERICAL RADIUS WAS PRODUCED IN ACCORDANCE WITH SPECIFICATIONS, AND ALL INSPECTION CHECKPOINTS CONFIRMED COMPLIANCE. THE POST-USE VISUAL CONDITION OF THE RETURNED DEVICE WAS ATTRIBUTED TO HANDLING AND STORAGE DELAYS PRIOR TO DECONTAMINATION, RATHER THAN A PRODUCT DEFECT. WHILE THE SURGEON PERCEIVED AN ATYPICAL GEOMETRY OR FINISH DURING SURGERY, NO EVIDENCE FROM MANUFACTURING, SUPPLIER PROCESSING, INSPECTION, OR DHR DOCUMENTATION SUPPORTS A NONCONFORMANCE. THIS COMPLAINT DOES NOT REPRESENT A PRODUCT QUALITY ISSUE. THE IMPLANT WAS MANUFACTURED AND RELEASED WITHIN SPECIFICATION, AND ALL INSPECTION SYSTEMS WERE VALIDATED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Description of Event or Problem · 0

    "SURGEON FOLLOWED SURGICAL TECHNIQUE TO PREPARE FOR IMPLANTATION. WHEN ACETABULUM WAS REAMED TO THE APPROPRIATE SIZE AND IMPLANT WAS OPENED FOR IMPLANTATION, SURGEON COULDN'T GET THE IMPLANT TO STICK TO THE BONE. FELT LIKE THE MANUFACTURING FINISH OF THE PRODUCT WASN'T THE USUAL STANDARD. SURGEON USES THIS TYPE OF SHELL ALL THE TIME AND NEVER HAD THIS ISSUE BEFORE. SURGEON WANTS TO KNOW IF THERE HAS BEEN ANY REPORTED ISSUES WITH THIS SHELL SIZE AND LOT NUMBER.". "THE SURGEON STATED THE SURFACE IN CONTACT WITH BONE WAS THE ISSUE, REFERRING TO THE SURFACE ON THE OUTER DIAMETER OF THE IMPLANT. THIS COULD BE CONSIDERED THE COATING.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2638296 PRIMARY TRIT HEMI CLUSTER HOLE CUP 56MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 07613327040166

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other