BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP IMP WIN GEN

    MDR report key: 8767483 · Received July 8, 2019

    Report

    Report Number
    0009613350-2019-00438
    Event Type
    Injury
    Date Received
    July 8, 2019
    Report Date
    October 18, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWZ
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 THE FINAL 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. TREND ANALYSIS: NO TREND ANALYSIS COULD BE PERFORMED AS NO ITEM NUMBER IS AVAILABLE. A TREND IS IDENTIFIED IF AT LEAST ONE OF THE FOLLOWING CRITERIA IS MET: 3 SIMILAR EVENTS WITHIN 1 MONTH FOR THE SAME ITEM NUMBER. 6 SIMILAR EVENTS WITHIN 6 MONTHS FOR THE SAME ITEM NUMBER. 2 SIMILAR EVENTS FOR THE SAME LOT NUMBER¨. DHR REVIEW: 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 GMBH 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 GMBH 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 PRODUCT WAS IMPLANTED ON AN UNKNOWN DATE AND REVISED IN (B)(6) 2018 DUE TO FALL AND DIFFICULTY TO WALK. 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. EVENT DESCRIPTION (EVENT DETAILS, PER) : EVENT SUMMARY: IT WAS REPORTED THAT PRODUCT WAS IMPLANTED ON AN UNKNOWN DATE AND REVISED IN (B)(6) 2018 DUE TO FALL AND DIFFICULTY IN WALK. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: THIS DEVICE IS INTENDED FOR TREATMENT. CONCLUSION SUMMARY: IT WAS REPORTED THAT PRODUCT WAS IMPLANTED ON AN UNKNOWN DATE AND REVISED IN (B)(6) 2018 DUE TO FALL AND DIFFICULTY TO WALK. IN VIVO TIME OF THE DEVICE IS UNKNOWN. THE SAME PATIENT UNDERWENT A FIRST REVISION SURGERY IN (B)(6) 2016 ; THIS CASE WAS REGISTERED UNDER (B)(4) (MFR 0009613350-2017-00497-1) AND INVOLVES DUROM HIP COMPONENTS. THE DHR CHECK COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. THE COMPATIBILITY CHECK COULD NOT BE PERFORMED AS NO PRODUCT INFORMATION WAS PROVIDED. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANT WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT 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. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. DUE TO THE INCOMPLETE INFORMATION, IFU/SURGICAL TECHNIQUE COULD NOT BE CONSIDERED AS PART OF THE INVESTIGATION. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    NO EVENT UPDATE.

    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. 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. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON THE UNKNOWN SIDE AND UNDERWENT REVISION SURGERY DUE TO A FALL AND DIFFICULTY IN WALK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561178 HIP IMP WIN GEN HIP IMP WIN GEN KWZ ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R