BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASUL, ALPHA INSERT, HOODED, MM/28

    MDR report key: 7533063 · Received May 22, 2018

    Report

    Report Number
    0009613350-2018-00544
    Event Type
    Injury
    Date Received
    May 22, 2018
    Date of Event
    April 26, 2018
    Report Date
    October 23, 2018
    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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY INVESTIGATION RESULT. DHR REVIEW: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: DISLOCATION EVENT DESCRIPTION: PATIENT WAS IMPLANTED WITH DURASUL INSERT COCR HEAD ON (B)(6) 2003 AND UNDERWENT REVISION ON (B)(6) 2018 DUE TO DISLOCATION. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICE ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING SAP DFMEA (ALPHA INSERT): IMPINGEMENT WITH STEM DUE TO WRONG DESIGN OF SHELL AND INSERT (EG. HOODED INSERT) POSSIBLE: AS NO X-RAYS WERE AVAILABLE IT CANNOT BE EXCLUDED THAT THERE WAS NO IMPINGEMENT WITH STEM. ROOT CAUSE DETERMINATION USING SAP DFMEA (COCR HEAD): INCREASED RELEASE OF WEAR PARTICLES, LOOSENING OF COMPONENTS, DISLOCATION DUE TO TISSUE IMPINGEMENT PRIOR TO PROPER TAPER FIT POSSIBLE: AS NO X-RAYS/SURGICAL NOTES WERE AVAILABLE IT CANNOT BE EXCLUDED THAT THERE WAS TISSUE IMPINGEMENT PRIOR TO PROPER TAPER FIT. INCREASED RELEASE OF PE WEAR PARTICLES, LOOSENING OF COMPONENTS, SUBLUXATION, DISLOCATION DUE TO IMPINGEMENT DUE TO INCORRECT POSITION OF STEM OR CUP POSSIBLE: AS NO X-RAYS/SURGICAL NOTES WERE AVAILABLE IT CANNOT BE EXCLUDED THAT THERE WAS IMPINGEMENT DUE TO INCORRECT POSITION OF STEM OR CUP. INCREASED RELEASE OF WEAR PARTICLES, LOOSENING OF COMPONENTS, SUBLUXATION, DISLOCATION DUE TO IMPINGEMENT OF COMPONENTS DUE TO MALPOSITION POSSIBLE: AS NO X-RAYS/SURGICAL NOTES WERE AVAILABLE IT CANNOT BE EXCLUDED THAT THERE WAS IMPINGEMENT OF COMPONENTS DUE TO MALPOSITION. CONCLUSION: PATIENT WAS IMPLANTED WITH DURASUL INSERT COCR HEAD ON (B)(6) 2003 AND UNDERWENT REVISION ON (B)(6) 2018 DUE TO DISLOCATION. NEITHER XRAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANTS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. THEREFORE, AN EXACT ROOT CAUSE FOR THE DISLOCATION AFTER 15 YEARS IN VIVO CANNOT BE DETERMINED THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN INSERT ON THE RIGHT SIDE. SUBSEQUENTLY (APPROXIMATELY 14 YEARS AFTER IMPLANTATION) PATIENT WENT TO REVISION SURGERY DUE TO DISLOCATION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM: MS-30, STEM, STANDARD, CEMENTED, 10, TAPER 12/14 CATALOG #: 300049100, LOT #: 2165974; ITEM: ALLOFIT ALLOCLASSIC, SHELL WITH POLAR SCREW PLUG, CATALOG #: 4249, LOT #: 2169243; ITEM: COCR HEAD 28/-4 'S' 12/14, CATALOG #: 14280520, LOT #: 2191186. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K013935. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. AN E-MAIL REQUESTING THE FOLLOWING ADDITIONAL INFORMATION WAS SENT ON (B)(6) 2018 TO THE APPROPRIATE REPRESENTATIVES. ·SURGICAL REPORTS. ·ALL AVAILABLE X-RAYS DURING TIME IN- VIVO WITH PRINTED DATE. ·ALL AVAILABLE INTRAOPERATIVE PICTURES. ·PATIENT DOB, WEIGHT, HEIGHT, BMI AND ALL RELEVANT HISTORY. ·WERE THERE ANY CONTRIBUTING CONDITIONS RELATED TO THE EVENT? (EX: TRAUMA, ILLNESS, PREVIOUS SURGERY, RELATED NONCOMPLIANCE, PATIENT ANATOMY). ·WAS THE SURGICAL TECHNIQUE FOR THE PRODUCT UTILIZED? A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. (B)(4). . THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350 - 2018 - 00545.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN INSERT ON THE RIGHT SIDE. SUBSEQUENTLY (APPROXIMATELY 14 YEARS AFTER IMPLANTATION) PATIENT WENT TO REVISION SURGERY DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376002 DURASUL, ALPHA INSERT, HOODED, MM/28 N/A JDI ZIMMER GMBH N/A 2118190

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R