BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM US ACETABULAR COMPONENT 60/54 T

    MDR report key: 3032716 · Received March 12, 2013

    Report

    Report Number
    9613350-2013-01415
    Event Type
    Other
    Date Received
    March 12, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE THE PRODUCTS SINCE THE PT HAS NOT BEEN REVISED TO DATE. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. A PRODUCT FAILURE CANNOT BE CONFIRMED. SHOULD ADD'L INFO BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. A TIGHT MONITORING IS ONGOING FOR REVISIONS WITH US DUROM CUPS WHERE THE INITIAL IMPLANT DATE OCCURRED AFTER THE RELAUNCH OF THE US DUROM CUP. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. THE DISTRIBUTION OF THIS PRODUCT WAS CEASED MEANWHILE DUE TO BUSINESS REASONS. ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS CASE WAS RE-OPENED TO ENTER ADDITIONAL INFORMATION WHICH WAS RECEIVED ON JULY 06, 2016. THIS ADDITIONAL INFORMATION DOES NOT CHANGE PREVIOUS MANUFACTURER'S ASSESSMENT OF THE CASE. ZIMMER CONSIDERS THIS CASE AS CLOSED AGAIN. SHOULD ANY DEVICE AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE ZIMMER WILL RE-EVALUATE THE CASE AND SEND AN AMENDED MEDICAL DEVICE REPORT. ZIMMER REFERENCE NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON AUGUST 16, 2017. PRODUCT WAS RECEIVED FOR INVESTIGATION AND THE RESULTS HAVE BEEN PROVIDED (B)(4) DHR REVIEW : THE QUALITY RECORDS INDICATE THAT THIS COMPONENT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT SUMMARY: PATIENT WAS REVISED DUE TO PAIN, LOOSENING AND ELEVATED METAL IONS. REVIEW OF RECEIVED DATA SURGICAL REPORT : REVIEW OF SURGICAL REPORT DID NOT LEAD TO NEW INFORMATION REGARDING THE REPORTED EVENT. OTHER INFORMATION & SOURCES: REVIEW OF THE COMPLAINT RELEVANT DOCUMENTS DID NOT LEAD TO NEW INFORMATION REGARDING THE REPORTED EVENT. COMPLEX PHYSIOLOGICAL REACTIONS LIKE PSEUDOTUMOR OR METAL ALLERGY ARE KNOWN RISKS FOR THIS KIND OF METAL-ON-METAL IMPLANTS AS STATED IN ZIMMER¿S "INSTRUCTION LEAFLET FOR ENDOPROSTHESIS". DEVICES ANALYSIS; THE RETURNED PARTS SHOWED DAMAGE FROM THE REVISION SURGERY SUCH AS NICKS AND SCRATCHES AND ARE PARTIALLY COVERED WITH SOME ORGANIC DEPOSITS. THE DUROM CUP SHOWS DAMAGE FROM THE REVISION SURGERY SUCH AS NICKS AND SCRATCHES. THE POROUS COATING OF THE DUROM ACETABULAR COMPONENT EXHIBITED POOR BONE ON GROWTH . ONLY FEW BONE TRACES VISIBLE. THE SURFACE OF LDH HEAD WAS SCRATCHED . ON THE INNER SURFACE OF THE HEAD ADAPTER SURFACE CHANGES DUE TO FRETTING CORROSION AS WELL AS ONE MARK OF UNKNOWN ORIGIN COULD BE FOUND. AN AREA ON THE ARTICULATING SIDE OF THE DUROM CUP IS COVERED WITH PARALLEL SCRATCHES SLIGHTLY EXTENDING OVER THE BEVEL OF THE SPHERICAL CALOTTE. AN AREA WITH PARALLEL DENSE SCRATCHES COULD BE OBSERVED ON THE HEAD. THE SCRATCHES OBSERVED ON THE CUP RIM AND THE SCRATCHES SEEN ON THE HEAD COULD PROBABLY POINT TO A SUBLUXATION OR RIM LOADING SITUATION. CONCLUSION: NO FURTHER INVESTIGATION REQUIRED AS THIS ISSUE IS KNOWN (ERROR PATTERN: POTENTIAL EARLY REVISION OF THE ACETABULAR COMPONENT DUE TO LOOSENING, IMPLANT MIGRATION OR UNRESOLVED PAIN, HIGHER ION RELEASE). AT LEAST ONE OF THESE ERROR PATTERNS IS OBSERVED IN THIS EVENT. A TIGHT MONITORING IS ONGOING FOR REVISIONS WITH US DUROM CUPS WHERE THE INITIAL IMPLANT DATE OCCURRED AFTER THE RELAUNCH OF THE US DUROM CUP. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. THE DISTRIBUTION OF THIS PRODUCT WAS CEASED MEANWHILE DUE TO BUSINESS REASONS. ZIMMER GMBH CONSIDERS THIS CASE AS CLOSE. SHOULD ANY ADDITIONAL INFORMATION THAT CHANGES THE ASSESSMENT BECOME AVAILABLE TO US, OR ANY EXTRA DEMAND BE REQUESTED, WE WILL RE-EVALUATE THE CASE.ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY PT'S COUNSEL THAT THE PT RECEIVED A DUROM US ACETABULAR COMPONENT 60/54 T ON (B)(6) 2009. THE PT IS CURRENTLY BEING MONITORED DUE TO PAIN AND LOOSENING.

    Description of Event or Problem · 1

    IT WAS NOW REPORTED THAT THE PATIENT RECEIVED A DUROM US ACETABULAR COMPONENT 60/54 T ON (B)(6) 2009 ON THE LEFT . THE PATIENT IS CURRENTLY BEING MONITORED DUE TO PAIN AND LOOSENING. IT WAS ADDITIONALLY MENTIONED THAT THE PATIENT IS HAVING ELEVATED METAL ION LEVELS IN THE BLOOD. NOTE: THIS IS A BILATERAL PATIENT, THE RIGHT SIDE IS REPORTED UNDER (B)(4).

    Description of Event or Problem · 1

    PRODUCT RECEIVED. PATIENT WAS REVISED ON UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104262 DUROM US ACETABULAR COMPONENT 60/54 T DUROM US ACETABULAR COMPONENT KWA ZIMMER GMBH 2423583

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| O| R