BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA HEAD, 12/14, 36 X 0

    MDR report key: 5401458 · Received February 1, 2016

    Report

    Report Number
    9613350-2016-00028
    Event Type
    Injury
    Date Received
    February 1, 2016
    Date of Event
    December 28, 2009
    Report Date
    June 29, 2020
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    AS PER FDA¿S DIRECTIVE, MEDWATCH REPORT HAS BEEN RESUBMITTED FOR REMOVING THREE ZEROS IN THE PREFIX OF MFR NUMBER(0009613350-2016-00028-1). ALL THE INFORMATION CAPTURED AS PER 0009613350-2016-00028-1 INCLUDING G4(DATE RECEIVED BY MANUFACTURER) EXCEPT B4. AS THE CASE AT HAND IS A LEGAL CLAIM IT IS NOT SUSPECTED THAT THE DEVICES OR ADDITIONAL INFORMATION ARE BEING SUBMITTED FOR REVIEW. ZIMMER GMBH WINTERTHUR LEGAL DEPARTMENT HAVE ALREADY PASSED ALL INFORMATION THAT WAS RECEIVED FROM THE LAWYER, TO OUR COMPLAINT HANDLING DEPARTMENT. BY EXPERIENCE ZIMMER GMBH NEVER GETS MORE INFORMATION EXCEPT FOR THE ONE THAT HAS BEEN ALREADY COVERED IN THE FINAL REPORT. PATIENTS¿ ADVOCATES ONLY PROVIDE TO ZIMMER GMBH AS MUCH INFORMATION AS THEY ARE WILLING TO SHARE TO PROTECT THE RIGHTS OF THEIR CLIENTS. ALL INFORMATION WHICH HAS BEEN PROVIDED FOR THIS PARTICULAR CASE IS ALREADY COVERED IN THIS FOLLOW UP REPORT. NEVERTHELESS, SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE TO US, A FOLLOW UP REPORT WILL BE SUBMITTED. A TECHNICAL INVESTIGATION WAS NOT POSSIBLE TO BE PERFORMED, AS THE DEVICE(S) WERE NOT AT HAND FOR INVESTIGATION. HOWEVER, BASED ON THE AVAILABLE INFORMATION THE INVESTIGATION IS CONDUCTED WITH OUTCOME AS FOLLOWS. DHR REVIEW: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND WAS IDENTIFIED. COMPATIBILITY CHECK: THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED. EVENT SUMMARY: IT WAS REPORTED THAT PATIENT RECEIVED A ZIMMER M/L KINECTIVE STEM WITH A KINECTIV NECK, A BIOLOX CERAMIC HEAD AND A TRILOGY LONGEVITY CONSTRAINED LINER ON NOVEMBER 23, 2009 AND WAS REVISED ON DECEMBER 28, 2009 DUE TO DISLOCATIONS. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS WERE RECEIVED. DEVICES ANALYSIS: A DEVICE ANALYSIS WAS NOT POSSIBLE TO PERFORM, AS NO PRODUCT WAS RETURNED TO ZIMMER GMBH FOR IN-DEPTH ANALYIS. ROOT CAUSE ANALYSIS: 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 ANALYSIS OF THE REPORTED EVENT. HOWEVER, ALL POSSIBLE CAUSES RELATED TO THE ISSUES REPORTED ARE LISTED IN DFMEA. DISLOCATION ON HIP SYSTEM ARE OFTEN RELATED TO CUP POSITION. DUE TO MISSING INFORMATION (ESPECIALLY NO-XRAYS RECEIVED) IT IS IMPOSSIBLE TO DETERMINE THE CUP POSITION. HOWEVER, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT REVISION SURGERY DUE TO DISLOCATION.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES OR X-RAYS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. DUE TO FACT THAT THIS IS A LEGAL CLAIM, OUR LEGAL DEPARTMENT HAS BEEN PROVIDED WITH THE AVAILABLE FACTS FROM THE CUSTOMER. ZIMMER GMBH (B)(4) LEGAL DEPARTMENT IS WELL TRAINED AND PASSES ALL INFORMATION CONCERNING THE CASE TO OUR COMPLAINT HANDLING DEPARTMENT. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. 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).

    Description of Event or Problem · 1

    THE PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM. IT WAS REPORTED, THAT THE PATIENT WAS IMPLANTED A BIOLOX DELTA HEAD, 12/14, 36 X 0 ON THE RIGHT SIDE ON (B)(6) 2009. ON (B)(6) 2009, PATIENT UNDERWENT A REVISION SURGERY ON HER RIGHT HIP DUE TO DISLOCATION. (SAME CASE IS TREATE IN (B)(4), ZIMMER INC., (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60109 BIOLOX DELTA HEAD, 12/14, 36 X 0 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER GMBH N/A 2503677

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R