BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARSTEM MODULAR HEAD FOR 21000662

    MDR report key: 17476341 · Received August 7, 2023

    Report

    Report Number
    9613369-2023-00175
    Event Type
    Malfunction
    Date Received
    August 7, 2023
    Date of Event
    July 15, 2023
    Report Date
    August 25, 2023
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    LXH
    UDI-DI
    07611996114393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT SURGERY, A PIECE OF A POLARSTEM MODULAR HEAD FOR 21000662 BROKE OFF. NO PATIENT INJURY WAS REPORTED DUE TO THIS ISSUE. THE DEVICE INTENDED FOR USE IN TREATMENT WAS NOT RETURNED FOR INVESTIGATION. A PRODUCT EVALUATION WAS NOT POSSIBLE. NO BATCH NUMBER WAS COMMUNICATED SO THE PRODUCTION HISTORY REVIEW WAS NOT POSSIBLE. DUE TO AN UNKNOWN BATCH NUMBER, THE REVIEW OF HISTORICAL COMPLAINTS WAS PERFORMED ON PRODUCT NUMBER BASIS ONLY, REVEALING 42 ADDITIONAL COMPLAINTS OVER THE PAST 12 MONTHS WITH SIMILAR FAILURE MODE. DUE TO INSUFFICIENT INFORMATION IT IS NOT POSSIBLE TO PERFORM A REVIEW OF PAST CORRECTIVE ACTIONS. A REVIEW OF THE RISK MANAGEMENT DOCUMENTATION VERIFIES THE FAILURE MODE, OCCURRENCE AND SEVERITY OF THE REPORTED ISSUE. THE PERFORMED INVESTIGATION DOES NOT LEAD TO AN ACCURATELY DETERMINED CAUSE. BASED ON THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO INVESTIGATE WHETHER THE REPORTED DEVICE MET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. DUE TO INSUFFICIENT INFORMATION, IT IS NOT POSSIBLE TO INDICATE FACTORS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ACCORDING TO DOCUMENT "PROCESSING (CLEANING, DISINFECTION AND STERILIZATION) OF INSTRUMENTS FROM SMITH & NEPHEW ORTHOPAEDICS AG" (LIT. N°03389-EN 1363 V3 11/19), ALL DEVICES MUST BE INSPECTED AND CONTROLLED FOR PROPER FUNCTIONING AFTER CLEANING/DISINFECTION. THERE IS NO NEED FOR FURTHER ACTIONS BECAUSE OF THE LIMITED INFORMATION PROVIDED. NEVERTHELESS, SMITH + NEPHEW WILL CONTINUE TO MONITOR THIS DEVICE FOR SIMILAR ISSUES. THIS COMPLAINT WILL BE REOPENED SHOULD ADDITIONAL INFORMATION OR THE DEVICE BE RECEIVED.

    Additional Manufacturer Narrative · 0

    INTERNAL REFERENCE NUMBER: (B)(4). SMITH & NEPHEW IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 C.F.R. PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING THR SURGERY, A PIECE OF A POLARSTEM MODULAR HEAD FOR 21000662 BROKE OFF. IT IS UNKNOWN IF THE INCIDENT CAUSED ANY DELAYS TO THE SURGERY OR HOW IT WAS COMPLETED. NO PATIENT INJURY WAS REPORTED DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318345 POLARSTEM MODULAR HEAD FOR 21000662 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SMITH & NEPHEW ORTHOPAEDICS AG UNKNOWN 07611996114393

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown