BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BICON-PLUS PE INSERT ANTIL 3/28 NON-CEM

    MDR report key: 13829748 · Received March 20, 2022

    Report

    Report Number
    9613369-2022-00053
    Event Type
    Injury
    Date Received
    March 20, 2022
    Date of Event
    August 16, 2007
    Report Date
    May 24, 2022
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    JDG
    PMA / PMN Number
    K992154
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: CASE-(B)(4).

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE NUMBER: CASE-(B)(4).

    Additional Manufacturer Narrative · 0

    H3, H6: IT WAS REPORTED THAT, AFTER A LEFT THA HAD BEEN PERFORMED ON (B)(6) 2003, THE PATIENT SUFFERED A DISLOCATION/SUBLUXATION. THIS EVENT WAS ADDRESSED VIA REVISION SURGERY ON 16-(B)(6) 2007. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM. THE DEVICE INTENDED FOR USE IN TREATMENT WAS NOT RETURNED FOR INVESTIGATION. AN EVALUATION OF THE COMPLAINED DEVICE COULD THEREFORE NOT BE CONDUCTED AND THE REPORTED FAILURE MODE COULD NOT INDEPENDENTLY BE CONFIRMED. A REVIEW OF THE BATCH RECORD REVEALED NO DEVIATIONS FROM THE STANDARD MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY REVEALED NO ADDITIONAL COMPLAINT FOR THE BATCH IN QUESTION. A REVIEW OF THE RISK MANAGEMENT DOCUMENTATION VERIFIES THE FAILURE MODE AND SEVERITY OF THE REPORTED ISSUE. REVIEW OF PAST CORRECTIVE ACTIONS WAS PERFORMED. NO FURTHER ESCALATION IS REQUIRED. THE IFU (LIT. NO. 12.23 ED 03/21 & LIT. NO. 5010100 12/03) LISTS DISLOCATION AS KNOWN POSSIBLE SIDE EFFECT/ COMPLICATION RESULTING FROM A HIP ARTHROPLASTY. WITHOUT CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION, A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON AVAILABLE INFORMATION, THE REPORTED FAILURE MODE CANNOT BE CONFIRMED. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE CANNOT BE CONFIRMED. THERE IS NO INDICATION THAT THE REPORTED DEVICE FAILED TO MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. DUE TO INSUFFICIENT INFORMATION IT IS NOT POSSIBLE TO SPECULATE ABOUT FACTORS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE ROOT CAUSE FOR THE REPORTED DISLOCATION IS STAYS UNDETERMINED. THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. THIS COMPLAINT WILL BE REOPENED SHOULD ADDITIONAL INFORMATION OR THE DEVICE BE RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER 1090 PRIMARY THA SURGERIES IN WHICH A BICON-PLUS ACETABULAR SUB-SYSTEM HAD BEEN IMPLANTED, THERE HAS BEEN 84 REVISION SURGERIES FOR UNSPECIFIED REASONS. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE (B)(6), FOLLOWING A REVIEW OF THE DATA CONDUCTED IN SEPTEMBER 2021. INSPECTION OF THE DATA SHOWS THAT THE CALCULATED PTIR (REVISION RATE PER ONE HUNDRED PATIENT YEARS OF IMPLANTATION) OF BICON-PLUS IS ABOVE THE AVERAGE [071 (0.57-0.88)] FOR THEIR GROUP PTIR¿S [0.38].

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER A LEFT THA HAD BEEN PERFORMED ON (B)(6) 2003, THE PATIENT SUFFERED A DISLOCATION/SUBLUXATION. THIS EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2007 TO EXPLANT THE BICON-PLUS PE INSERT ANTIL 3/28 NON-CEM. PATIENT HEALTH STATUS IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518085 BICON-PLUS PE INSERT ANTIL 3/28 NON-CEM PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL JDG SMITH & NEPHEW ORTHOPAEDICS AG 0305.60.1092

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Hospitalization| R