BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITAN, DISTAL PART, CURVED, UNCEMENTED, 22/140

    MDR report key: 7845346 · Received September 5, 2018

    Report

    Report Number
    0009613350-2018-00993
    Event Type
    Injury
    Date Received
    September 5, 2018
    Report Date
    November 23, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. CORRECTED INFORMATION ARE FILLED IN THE FOLLOWING FIELDS: PLEASE VOID THE REPORT 0009613350-2018-00993 AND ALL ASSOCIATED REPORTS (INCLUDED THIS ONE) BECAUSE THEY ARE DUPLICATE OF THE REPORT 0009613350-2016-01381 (AND ASSOCIATED). ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 0

    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. ADDITIONAL INFORMATION WAS RECEIVED AND IS FILED IN THIS REPORT. 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 · 0

    IT WAS FOUND THAT THIS COMPLAINT (B)(4) IS A DUPLICATE OF (B)(4) . THEREFORE (B)(4) WILL BE SET TO NOT-A-COMPLAINT. PATIENT NAME, ITEM AND LOT NUMBERS ARE IDENTICAL. IN (B)(4) NO EVENT DETAIL, RESPECTIVELY NO INFORMATION CONCERNING ANY PRODUCT FAILURE HAS BEEN REPORTED. THE ONLY AVAILABLE INFORMATION WAS, THAT THERE IS A LEGAL CASE ONGOING. THIS INFORMATION WILL BE ADDED TO (B)(4) . PLEASE VOID THE REPORT 0009613350-2018-00993 AND ALL ASSOCIATED REPORTS (INCLUDED THIS ONE) BECAUSE THEY ARE DUPLICATE OF THE REPORT 0009613350-2016-01381 (AND ASSOCIATED).

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATE, DETAIL OF PRODUCT: ITEM # 0100010816,, ITEM NAME ALPHA INSERT, PE, HOODED, PP/32 LOT # 2338219. ITEM # 4272, ITEM NAME ALLOFIT-S ALLOCLAS SHELL 66/PP, LOT # 2542342. ITEM # 0100402065, ITEM NAME REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 65, TAPER 12/14, LOT # 2614455. ITEM # 173207, ITEM NAME SULOX, HEAD, L, 32/+3.5, TAPER 12/14, LOT # 2610463. ITEM # 430107035, ITEM NAME 35 MM LENGTH X 6.5 MM TI FULLY THREADED CANCELLOUS BONE SCREW, LOT # UNKNOWN. ITEM # 430107040, ITEM NAME 40 MM LENGTH X 6.5 MM TI FULLY THREADED CANCELLOUS BONE SCREW, LOT # UNKNOWN. ITEM # 430107050, ITEM NAME 50 MM LENGTH X 6.5 MM TI FULLY THREADED CANCELLOUS BONE SCREW, LOT # UNKNOWN. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW, NEITHER THE DEVICE HAS BEEN RECEIVED FOR INVESTIGATION AS THE PATIENT HAS NOT BEEN REVISED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. 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. (B)(4).

    Description of Event or Problem · 1

    A PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM FOR UNKNOWN REASON. THE PATIENT HAD AN INFECTION HISTORY IN 2011, BEFORE THE IMPLANTATION OF THE ZIMMER BIOMET DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688210 REVITAN, DISTAL PART, CURVED, UNCEMENTED, 22/140 N/A LZO ZIMMER GMBH N/A 2442156

    Patients

    Seq Age Sex Outcome Treatment
    1