BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL, ALPHA INSERT, II/32

    MDR report key: 6401945 · Received March 14, 2017

    Report

    Report Number
    0009613350-2017-00372
    Event Type
    Injury
    Date Received
    March 14, 2017
    Date of Event
    February 21, 2017
    Report Date
    March 14, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    LPH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4). THE ACTUAL DEVICE REPORTED IN SECTION D IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E DURASUL ALPHA INSERT NEUTRAL Ø GG/32) ARE MARKETED IN USA, AND THEREFORE, THIS REPORT WAS FILED.

    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 THEREFOR TRIED SEVERAL TIMES TO RECEIVE MORE INFORMATION FOR THIS CASE. TREND ANALYSIS: NO TREND IDENTIFIED. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT SUMMARY: PATIENT HAD METASUL HEAD AND LINER IM PLANTED ON (B)(6) 2007 AND THE PRODUCTS WERE REVISED ON (B)(6) 2017 DUE TO PAIN, ALVAL REACTION. NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION - THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. - A TISSUE REACTION LIKE ALVAL OR METAL ALLERGY CAN BE A POST-OPERATIVE RISK FOR METAL ON METAL (MOM). THESE ARE KNOWN RISKS FOR THIS KIND OF METAL-ON-METAL IMPLANTS AS STATED IN ZIMMER¿S INSTRUCTION LEAFLET FOR ENDOPROSTHESES. ROOT CAUSE ANALYSIS - PATIENT HAD METASUL HEAD AND LINER IMPLANTED ON (B)(6) 2007 AND THE PRODUCTS WERE REVISED ON (B)(6) 2017 DUE TO PAIN, ALVAL REACTION. HEAD AND LINER EXCHANGE PERFORMED. NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANT(S) WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT(S) 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. A TISSUE REACTION LIKE ALVAL OR METAL ALLERGY CAN BE A POST-OPERATIVE RISK FOR METAL ON METAL (MOM). THESE ARE KNOWN RISKS FOR THIS KIND OF METAL-ON-METAL IMPLANTS AS STATED IN ZIMMER¿S INSTRUCTION LEAFLET FOR ENDOPROSTHESES. HOWEVER, ALL POSSIBLE CAUSES RELATED TO THE ISSUES REPORTED ARE LISTED IN DFMEA OF THE DEVICE. CONCLUSION SUMMARY - PATIENT HAD METASUL HEAD AND LINER IMPLANTED ON (B)(6) 2007 AND THE PRODUCTS WERE REVISED ON (B)(6) 2017 DUE TO PAIN, ALVAL REACTION. HEAD AND LINER EXCHANGE PERFORMED. NEITHER X-RAYS, 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. A TISSUE REACTION LIKE ALVAL OR METAL ALLERGY CAN BE A POST-OPERATIVE RISK FOR METAL ON METAL (MOM). THESE ARE KNOWN RISKS FOR THIS KIND OF METAL-ON-METAL IMPLANTS AS STATED IN ZIMMER¿S INSTRUCTION LEAFLET FOR ENDOPROSTHESES. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A METASUL ALPHA INSERT, II/32 ON (B)(6) 2007 AND UNDERWENT REVISION SURGERY ON (B)(6) 2017 DUE TO ALVAL (ASEPTIC LYMPHOCYTIC VASCULITIS ASSOCIATED LESION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185376 METASUL, ALPHA INSERT, II/32 UNKNOWN LPH ZIMMER GMBH N/A 2394626

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R