BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABULAR COMPONENT 54/48 N

    MDR report key: 1938731 · Received December 13, 2010

    Report

    Report Number
    9613350-2010-00590
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    August 31, 2010
    Report Date
    November 3, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER, INC., WHICH MARKETS THE DEVICES IN THE U.S. THE MFR DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THE REVISION SURGERY IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN 07/2008. SHOULD ADD'L INFO BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURE IS NOT INDICATED AT THIS TIME AND ZIMMER GMBH CONSIDERS THIS CASE CLOSED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE RESULTS OF THE INVESTIGATION WERE PROVIDED. DHR REVIEW: THE QUALITY RECORDS INDICATE THAT THESE COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT DESCRIPTION EVENT SUMMARY: PATIENT UNDERWENT REVISION DUE TO LOOSENING. 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 VISUAL EXAMINATION: FOLLOWING COMPONENTS HAVE BEEN RETURNED FOR INVESTIGATION: DUROM CUP AND LDH HEAD AND HEAD ADAPTER AND KINECTIV MODULAR NECK AND AN INSTRUMENT. ALL RECEIVED COMPONENTS SHOW DAMAGE FROM REVISION SURGERY SUCH AS NICKS AND SCRATCHES. ADDITIONALLY, FOLLOWING OBSERVATIONS ARE DONE: THE DUROM CUP SHOWS NONE BONE ON-GROWTH ON THE ANCHORING SIDE. THE DUROM CUP SHOWS SIGNS OF LOOSENING IN FORM OF SLIGHTLY POLISHED AREAS ON THE ANCHORING SIDE. THE INNER SURFACE OF THE HEAD ADAPTER SHOWS SOME SURFACE CHANGES IN FORM OF FRETTING CORROSION THE OUTER SURFACE OF THE HEAD ADAPTER AND THE HEAD TAPER COULD NOT BE REVIEWED AS THE HEAD ADAPTER IS STILL ASSEMBLED IN THE LDH HEAD. AN INSTRUMENT IS STILL ASSEMBLED ON THE KINEKTIV NECK TAPER. CONCLUSION: NO FURTHER INVESTIGATION REQUIRED AS THIS ISSUE IS KNOWN AND ADDRESSED IN WT123080 (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. CORRECTIVE ACTION RELATED TO DUROM ISSUE IS REPORTED IN CAPA. SALES OF THE DUROM ACETABULAR COMPONENT WERE VOLUNTARILY AND TEMPORARILY SUSPENDED IN THE U.S. UNTIL IMPLEMENTATION OF THE CORRECTIVE ACTION IN 2008 (UPDATE OF SURGICAL TECHNIQUE BROCHURE AND INSTRUCTIONS FOR USE, AND A NEW U.S. SURGEON TRAINING PROGRAM). AFTER IMPLEMENTATION OF THE CORRECTIVE ACTION, SALES WERE RESUMED TO THOSE SURGEONS WHO COMPLETED THE MANDATORY U.S. SURGEON TRAINING PROGRAM. DUE TO LOW SALES, ZIMMER GMBH STOPPED SELLING THE DUROM ACETABULAR COMPONENT IN THE U.S. AT THE END OF 2010. A CAPA EFFECTIVENESS CHECK WAS COMPLETED IN OCTOBER 2010 CONFIRMING THAT THE CORRECTIVE ACTION RESULTED IN A DECREASE IN TOTAL COMPLAINTS. SHOULD ANY ADDITIONAL INFORMATION THAT CHANGES THE ASSESSMENT BECOME AVAILABLE TO US, OR ANY EXTRA DEMAND BE REQUESTED, WE WILL REEVALUATE THE CASE. ZIMMER GMBH CONSIDER THIS CASE AS CLOSED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT UNDERWENT REVISION SURGERY ON (B)(6) 2010 DUE TO IMPLANT (CUP) LOOSENING ((B)(6) 2010). THA WAS ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM US ACETABULAR COMPONENT 54/48 N DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2357510

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| O