BEUDAMED
    FDA Adverse Event Injury Summary report: N

    B-S REINFORCEMENT CAGE HIP IMPLANT

    MDR report key: 6217800 · Received January 3, 2017

    Report

    Report Number
    0009613350-2017-00011
    Event Type
    Injury
    Date Received
    January 3, 2017
    Report Date
    December 6, 2016
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS THE CASE AT HAND WAS TAKEN FROM A JOURNAL ARTICLE IT IS NOT SUSPECTED THAT THE DEVICE OR ADDITIONAL INFORMATION IS BEING SUBMITTED FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS CMP-(B)(4).

    Additional Manufacturer Narrative · 1

    AS FOR ZIMMER SPECIALISTS TO PERFORM AN IN-DEPTH ANALYSIS IT IS REQUIRED TO HAVE ALL NECESSARY INFORMATION AT HAND, IT WAS THEREFORE TRIED SEVERAL TIMES TO RECEIVE MORE INFORMATION FOR THIS CASE, BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. DEVICE HISTORY RECORDS (DHR): AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. AT ZIMMER (B)(4) ALL MEDICAL DEVICES PRIOR RELEASE TO MARKET UNDERGO SEVERAL QUALITY INSPECTIONS AS DEFINED IN OUR QUALITY PROCEDURES. OUR QUALITY INSPECTION- AND DEVIATION PROCEDURES ENSURE THAT ONLY PRODUCTS FULFILLING THE SPECIFICATION ARE SOLD. THESE PROCEDURES ARE PART OF THE OVERALL QUALITY MANAGEMENT SYSTEM AT ZIMMER (B)(4) AND GET REGULARLY AUDITED BY OUR NOTIFIED BODY, COMPETENT AUTHORITIES AND INTERNAL AND EXTERNAL AUDITORS. THUS, FOR ALL PRODUCTS SOLD TO THE MARKET CAN BE ASSUMED HAVING A COMPLETE AND CORRECT DHR. TREND ANALYSIS: N/A AS NO ITEM NUMBER WAS AVAILABLE. REVIEW OF EVENT DESCRIPTION: EVENT SUMMARY: THE AVAILABLE INFORMATION REPORTS THE REVISION OF A B-S RING IMPLANTED IN A (B)(6) PATIENT WHICH WAS REVISED AFTER 54 MONTHS (APPROX. 4.5 YEARS) DUE TO RECURRING DISLOCATION AND ASEPTIC LOOSENING. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ROOT CAUSE DETERMINATION USING DFMEA: LOOSENING: - ASEPTIC LOOSENING DUE TO INSUFFICIENT PRIMARY STABILITY DUE TO DESIGN => NOT POSSIBLE, A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF COMPLAINT TRENDING DEFINED IN COMPLAINT REGISTRATION OR IN THE CURRENT PMS PROCESS. - ASEPTIC LOOSENING, MIGRATION OF IMPLANT DUE TO INSUFFICIENT SECONDARY STABILITY DUE TO SURFACE STRUCTURE => NOT POSSIBLE, A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF COMPLAINT TRENDING DEFINED IN COMPLAINT REGISTRATION OR IN THE CURRENT PMS PROCESS. - ASEPTIC LOOSENING, PAIN DUE TO INSUFFICIENT FATIGUE STRENGTH OF MATERIAL AND DESIGN, FRACTURE OF IMPLANT (MECHANICAL FAILURE OF THE RING / CAGE, MECHANICAL FAILURE OF THE FLANGES, MECHANICAL FAILURE OF THE HOOK, FAILURE OF BONE SCREWS). => NOT POSSIBLE, A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF COMPLAINT TRENDING DEFINED IN COMPLAINT REGISTRATION OR IN THE CURRENT PMS PROCESS. -STRESS SHIELDING LEADING TO ASEPTIC LOOSENING DUE TO INCORRECT DISTRIBUTION OF LOAD DUE TO DESIGN. => NOT POSSIBLE, A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF COMPLAINT TRENDING DEFINED IN COMPLAINT REGISTRATION OR IN THE CURRENT PMS PROCESS. - ASEPTIC LOOSENING DUE TO RELEASE OF WEAR PARTICLES (METAL AND CEMENT),BONE TO CAGE / CAGE TO CEMENTSCREW TO CAGE / SCREW TO CEMENT. => POSSIBLE, AS AFFECTED PRODUCT WAS NOT RETURNED FOR INVESTIGATION. - ASEPTIC LOOSENING DUE TO FAILURE OF CONNECTION RING / CAGE AND BONE SCREW. => POSSIBLE, AS AFFECTED PRODUCT WAS NOT RETURNED FOR INVESTIGATION. - ASEPTIC LOOSENING DUE TO LOSS OF BINDING SAFETY OF THE CEMENT INTERFACES:RING / CAGE - BONE CEMENT - CUP. => POSSIBLE, AS AFFECTED PRODUCT WAS NOT RETURNED FOR INVESTIGATION. - FRACTURE/ DAMAGE / LOOSENING OF IMPLANT DUE TO PATIENT DISREGARDS LIMITS OF THE DEVICE/WRONG BEHAVIOR OF THE PATIENT/HIGH PATIENT ACTIVITY. => POSSIBLE, AS NO DETAILS ABOUT PATIENT BEHAVIOR IS KNOWN. - STRESS SHIELDING LEADING TO ASEPTIC LOOSENING DUE TO INCORRECT DISTRIBUTION OF LOAD DUE TO INSUFFICIENT BONY SUPPORT OF IMPLANT => POSSIBLE, AS NO X-RAYS WERE PROVIDED. - ASEPTIC LOOSENING DUE TO WRONG CEMENTING TECHNIQUE. => POSSIBLE, AS NO DETAILS ABOUT THE SURGICAL TECHNIQUE ARE KNOWN. - INCREASED WEAR,LOOSENING OR FRACTURE OF COMPONENTS DUE TO PATIENT WITH HIGH BODY WEIGHT. => POSSIBLE, AS NO PATIENT DETAILS ARE KNOWN. DISLOCATION: - IMPINGEMENT WITH STEM (DECREASED ROM), DISLOCATION, SUBLUXATION,MIGRATION OF IMPLANT,STRESS SHIELDING DUE TO MALPOSITIONING OF THE IMPLANT, WRONG ALIGNMENT => POSSIBLE: BASED ON THE GIVEN INFORMATION IT CANNOT BE EXCLUDED. CONCLUSION SUMMARY: NEITHER X-RAYS, OPERATIVE NOTES, NOR OFFICE VISIT NOTES WERE RECEIVED FOR A DEEP ASSESSMENT. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), RELEVANT MEDICAL HISTORY AND ADHERENCE TO REHABILITATION PROTOCOL ARE UNKNOWN. DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. BASED ON THE INFORMATION AVAILABLE FOR THE INVESTIGATION, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THE PATIENT WAS IMPLANTED AN UNKNOWN B-S REINFORCEMENT CAGE HIP IMPLANT. THE EXACT DATE OF IMPLANTATION IS UNKNOWN. IMPLANTATION WAS PERFORMED BETWEEN 1980 AND 2000 WITH A BURCH-SCHNEIDER RING IN 55 CASES (87.3%), AN EICHLER RING IN SIX CASES (9.5%), AND OTHER RINGS IN TWO (3.2%). THIS COMPLAINT TREATS THE REVISION OF A B-S RING IMPLANTED IN A (B)(6) PATIENT. THE PATIENT UNDERWENT A REVISION SURGERY AFTER 54 MONTHS DUE TO ASEPTIC LOOSENING, RECURRENT DISLOCATION AND A LOOSE, MIGRATING SUPPORT RING. THE ORIGINAL BONE ALLOGRAFT HAD INCORPORATED, ENABLING FURTHER RECONSTRUCTION WITH A CEMENTED ACETABULAR COMPONENT. (F. A. CARROLL ET AL: THE SURVIVAL OF SUPPORT RINGS IN COMPLEX ACETABULAR REVISION SURGERY, IN: THE JOURNAL OF BONE & JOINT SURGERY (2008), VOL.90-B, NO.5.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2665 B-S REINFORCEMENT CAGE HIP IMPLANT UNKNOWN JDI ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R