BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLW INSERT 32 WITH RIM

    MDR report key: 8454844 · Received March 27, 2019

    Report

    Report Number
    0009613350-2019-00161
    Event Type
    Injury
    Date Received
    March 27, 2019
    Report Date
    September 25, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. CONCOMITANT MEDICAL PRODUCTS ACCORDING D11: ITEM NUMBER: 0105000156 ITEM NAME: ANELLO CPC DIAM.56 LOT #: 080118A. ITEM NUMBER: 0540323 ITEM NAME: METAL/METAL HEAD ADLER ORTHO LOT #: R0584. ITEM NUMBER: 0449220 ITEM NAME: MUDOLA NECK 12/14 ADLER ORTHO LOT #: E3402. ITEM NUMBER: 0103103 ITEM NAME: ALATA NOVA HIP STEM ADLER ORTHO LOT #: E2316. DHR REVIEW: REF:(B)(4) ; LOT:2478562. - YIELD:20. - DELIVERED:19. - SCRAPPED:01. - REASON FOR SCRAPPING:SET UP ISSUEE THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED AS THE HARM IS UNKNOWN. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED ON (B)(6) 2009 WITH A CLW HOODED INSERT, A ANELLO CUP AND AN ADLER METAL FHEAD, MODULAR NECK AND FEMORAL STEM AND CLAIMS TO HAVE DAMAGES. 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 AS IT REMAINS IMPLANTED. REVIEW OF PRODUCT DOCUMENTATION: - ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. - COMPATIBILITY: THE COMBINATION OF THE ZIMMER IMPLANTS IN COMBINATION WITH COMPETITOR'S PRODUCTS (ADLER ORTHO) IS AN OFF-LABLE USE AND NOT COMPATIBLE. - SURGICAL TECHNIQUE: DUE TO THE OFF-LABEL USE, THE SURGICAL TECHNIQUE HAS NOT BEEN FOLLOWED. CONCLUSION SUMMARY: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED ON (B)(6) 2009 WITH A CLW HOODED INSERT, A ANELLO CUP AND AN ADLER METAL HEAD, MODULAR NECK AND FEMORAL STEM AND CLAIMS TO HAVE DAMAGES. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR EVENT DETAILS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS 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. THE COMBINATION OF THE ZIMMER IMPLANTS IN COMBINATION WITH COMPETITOR'S PRODUCTS (ADLER ORTHO) IS AN OFF-LABLE USE. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. THEREFORE, AN EXACT ROOT CAUSE CANNOT BE DETERMINED. AN OFF-LABEL USE HAS BEEN PERFORMED. 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

    INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    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. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ITEM# 67.32.61, LOT# 2478562, CLW INSERT 32 WITH RIM; ITEM# 01.05000.156, LOT# 080118A, ANELLO CPC DIAM.56; ITEM# 0540323, LOT# R0584 ADLER ORTHO METAL/METAL HEAD, DIAMETER 32, LONG(+4); ITEM# 0449220, LOT# E3402 ADLER ORTHO MODULA NECK 12/14 S.C. SIZE: 9Y; ITEM# 0103103, LOT# E2316 ADLER ORTHO ALATA NOVA HIP STEM SIZE: 8. DEVICE EVALUATED BY MANUFACTURER: REMAINS IMPLANTED. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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

    A PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM. IT WAS REPORTED THAT THE PRODUCT HAS BEEN IMPLANTED ON (B)(6) 2009. THE PATIENT IS BEING MONITORED DUE TO DAMAGES CAUSED BY ADLER MOM IMPLANTED WITH ZIMMER INSERT AND RING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249286 CLW INSERT 32 WITH RIM N/A KWA ZIMMER GMBH N/A 2478562

    Patients

    Seq Age Sex Outcome Treatment
    1 Other