BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKN. POLARCUP SHELL (UNKN. TYPE)

    MDR report key: 11617774 · Received April 6, 2021

    Report

    Report Number
    1020279-2021-02740
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    March 11, 2021
    Report Date
    April 26, 2022
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    JDH
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: IT WAS REPORTED THAT, DURING A THR A POLARCUP SHELL PLACEMENT FAILED. THE PLUGS COULD NOT BE REMOVED AND THE SCREWDRIVER TIP WAS DEFECTIVE. IT IS UNKNOW IF THERE WAS A DELAY OR HOW THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. THE DEVICE INTENDED FOR USE IN TREATMENT WAS NOT RETURNED FOR INVESTIGATION NOR WAS A BATCH NUMBER COMMUNICATED. AN APPROPRIATE INVESTIGATION COULD THEREFORE NOT BE CONDUCTED AND THE REPORTED FAILURE MODE COULD NOT INDEPENDENTLY BE CONFIRMED. THE SURGICAL TECHNIQUE (LIT NO. 01620-EN (1582) V7 10/20) DESCRIBES THE CORRECT REMOVAL OF THE POLARCUP PLUGS USING THE UNIDIRECTIONAL T HANDLE (75023347): "RELEASE THE PLUGS BY TURNING THE T-WRENCH IN THE DIRECTION INDICATED ON THE PLUG COVER." BASED ON THE LIMITED INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. 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

    H6: HEALTH EFFECT - CLINICAL CODE AND HEALTH EFFECT - IMPACT CODE H6: MEDICAL DEVICE PROBLEM CODE, D3: MANUFACTURER NAME, CITY AND STATE AND G1: MANUFACTURING SITE NAME AND ADDRESS THIS REPORT WAS INADVERTENTLY SUBMITTED UNDER MANUFACTURER NUMBER (B)(4), THE CORRECT MANUFACTURER NUMBER IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A THR A POLARCUP SHELL PLACEMENT FAILED. THE PLUGS COULD NOT BE REMOVED AND THE SCREWDRIVER TIP WAS DEFECTIVE. IT IS UNKNOWN IF THERE WAS A DELAY OR HOW THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515616 UNKN. POLARCUP SHELL (UNKN. TYPE) PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL JDH SMITH & NEPHEW ORTHOPAEDICS AG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown