BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 26/260

    MDR report key: 8554580 · Received April 26, 2019

    Report

    Report Number
    0009613350-2019-00266
    Event Type
    Injury
    Date Received
    April 26, 2019
    Date of Event
    March 30, 2019
    Report Date
    November 19, 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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL: EVALUATION CODES. CORRECTION: DATE OF EVENT, DATE RECEIVED BY MFR, TYPE OF REPORT, DEVICE EVALUATED BY MFR, ADDITIONAL NARRATIVE. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO TRIGGER CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: REVISION DUE TO IMPLANT FRACTURE. EVENT SUMMARY: IT WAS REPORTED THAT THE PATIENT (BMI= 54.1) UNDERWENT A REVISION SURGERY OF THE LEFT HIP DUE TO IMPLANT FRACTURE ON AN UNKNOWN DATE. SURGEON SAYS PROXIMAL AREA OF IMPLANT WAS NOT SUPPORTED AND PATIENT IS VERY HEAVY WITH WEAK BONE. IMPLANT IS REPORTED TO BE BROKEN AT THE COLLAR AREA. IT IS ALSO STATED THAT THIS IMPLANT BREAKAGE HAPPENED FOR THE SECOND TIME. NO INFORMATION FOR THE FIRST BREAKAGE IS GIVEN. REVIEW OF RECEIVED DATA: IMPLANT STICKERS WERE RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. SURGICAL TECHNIQUE IS NOT REVIEWED AS NO SURGICAL REPORT OF THE IMPLANTATION WAS RECEIVED TO CONFIRM WHETHER THE ST WAS FOLLOWED OR NOT. CONCLUSION SUMMARY: REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PRODUCT DID NOT IDENTIFY ANY DEVIATIONS OR ANOMALIES RELATED TO THE REPORTED EVENT. 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 IMPLANTS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. THEREFORE, BASED ON THE GIVEN INFORMATION THE COMPLAINT COULD NOT BE CONFIRMED AND AN EXACT ROOT CAUSE CANNOT BE DETERMINED. 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 CHANGE TO PREVIOUSLY REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM: CABLE CERCLAGE CABLE, CATALOG #: 00223200418, LOT #: 63102417; ITEM: CABLE CERCLAGE CABLE, CATALOG #: 00223200418, LOT #: 63170498; ITEM: CABLE CERCLAGE CABLE, CATALOG #: 00223200418, LOT #: 63102425; ITEM: CABLE CERCLAGE CABLE, CATALOG #: 00223200418, LOT #: 63175472; ITEM: BIOLOX DELTA, CERAMIC HEAD, CATALOG #: 00877504004, LOT #: 2708250; ITEM: REVITAN, PROXIMAL PART, CATALOG #: 0100401075, LOT #: 2823920. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K071723. THE MANUFACTURER DID NOT RECEIVE THE DEVICE YET, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350 - 2019 - 00265.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO IMPLANT FRACTURE ON AN UNKNOWN DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351896 REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 26/260 N/A KWA ZIMMER GMBH N/A 2611037

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R