BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL LDH, HEAD, 44, CODE J, TAPER 18/20

    MDR report key: 6971181 · Received October 24, 2017

    Report

    Report Number
    0009613350-2017-01491
    Event Type
    Injury
    Date Received
    October 24, 2017
    Report Date
    March 20, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    KXA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS WERE MADE AVAILABLE. THE ACTUAL DEVICE REPORTED IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E .METASUL KOPF 28, 12/14, GRÖSSE S/-3.5, K091973) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN METASUL HEAD ADAPTER, RE# UNKNOWN, LOT#UNKNOWN. THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT: 0009613350-2017-01490. 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 ADDITIONAL INFORMATION FOR THIS CASE. THE MISSING INFORMATION WAS REQUESTED AT COMPLAINANT THE LATEST ONE ON OCTOBER 18, 2017 BUT WAS NOT AVAILABLE. THE SURGEON REPLIED THAT HE DOES NOT WANT TO RELEASE ANY FURTHER INFORMATION. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: REVISION DUE TO PSEUDOTUMOR DEVICE HISTORY RECORDS (DHR): AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE MISSING DEVICE INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE. 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 REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT PATIENT UNDERWENT HIP SURGERY AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT UNDERWENT REVISION DUE TO PSEUDOTUMOR ON AN UNKNOWN DATE. 44 MM METASUL FEMORAL HEAD AND -4 MM METASUL NECK TAPER WERE REMOVED. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS WERE RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ACCORDING TO THE INFORMATION RECEIVED, THE PRODUCT LOCATION IS UNKNOWN. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING DFMEA: ADVERSE BODY REACTIONS (LIKE CYST FORMATION, PSEUDOTUMORS, ALVAL, METALLOSIS AND PAIN) DUE TO ION RELEASE DUE TO INCREASED ION RELEASE DUE TO INCREASED METAL SURFACE (WITHOUT WEAR AND FRETTING CORROSION) => POSSIBLE: NO MEDICAL DATA, NO PRODUCT RECEIVED. THEREFORE CANNOT BE EXCLUDED. ADVERSE BODY REACTIONS (LIKE CYST FORMATION, PSEUDOTUMORS, ALVAL, METALLOSIS AND PAIN) DUE TO ION RELEASE DUE TO INCREASED ION/WEAR RELEASE DUE TO INCREASED ARTICULAR DIAMETER => POSSIBLE: NO MEDICAL DATA, NO PRODUCT RECEIVED. THEREFORE CANNOT BE EXCLUDED. CONCLUSION SUMMARY: 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. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ROOT CAUSE ANALYSIS OF THE REPORTED EVENT. THEREFORE, AN EXACT ROOT CAUSE CANNOT BE DETERMINED. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A METASUL LDH, HEAD, 44, CODE J, TAPER 18/20 ON AN UNKNOWN DATE AND THE PATIENT UNDERWENT REVISION SURGERY ON AN UNKNOWN DATE DUE TO PSEUDOTUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751657 METASUL LDH, HEAD, 44, CODE J, TAPER 18/20 N/A KXA ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R