BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA HEAD, 12/14, 32 X 0

    MDR report key: 5391229 · Received January 26, 2016

    Report

    Report Number
    9613350-2016-00053
    Event Type
    Injury
    Date Received
    January 26, 2016
    Date of Event
    December 29, 2015
    Report Date
    June 29, 2020
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    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(0009613350-2016-00053-1). ALL THE INFORMATION CAPTURED AS PER 0009613350-2016-00053-1 INCLUDING G4(DATE RECEIVED BY MANUFACTURER) EXCEPT B4. DHR REVIEW RESULTS: 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 FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER. REVIEW OF REPORTED EVENT: IT WAS REPORTED THAT THE PATIENT SUBLUXED ANTERIORLY ON THE BED AFTER COMPLETION OF THE PROCEDURE, TEREFORE THE PATIENT WAS REVISED DUE TO THE DISLOCATION. REVIEW OF X-RAYS: THREE PREOPERATIVE X-RAYS WERE AVAILABLE. THE X-RAYS DO NOT SHOW THE IMPLANT. REVIEW OF SURGICAL REPORTS: THE NOTES OF THE PREOPERATIVE VISITS AND THE SURGICAL REPORT OF IMPLANTATION WERE PROVIDED. IT WAS REPORTED THAT THE TRILOGY CUP WAS IMPLANTEDAT APPROXIMATELY 40 DEGREES ABDUCTION AND 20 DEGREES ANTEVERSION. THE STEM SIZE ( 12.5MM) WAS CHOSEN TO GAIN SOME ADDITIONAL LENGTH AND OFFSET. THE HIP COULD NOT BE DISLOCATED ANTERIORLY IN FULL EXTENSION AND MAXIMUM ER BUT THERE WAS NEAR IMPINGEMENT. IT WAS REPORTED THAT LENGTH, OFFSET AND ANTEVERSION HAD BEEN OPTIMIZED AND THAT INCREASING ANTEVERSION WOULD RISK POSTERIOR IMPINGEMENT AND ANTERIOR DISLOCATION. NO PRODUCT WAS AVAILABLE FOR INVESTIGATION. REVIEW OF SURGICAL TECHNIQUES: SURGICAL TECHNIQUE FOR ZIMMER TRILOGY IT ACETABULAR SYSTEM STATES: 45 DEGREES OF ABDUCTION AND 20 DEGREES OF FORWARD FLEXION IS RECOMMENDED IN MOST CASES. ROOT CAUSE ANALYSIS: POSSIBLE CAUSES FOR THE REPORTED EVENT ACCORDING TO SAP DFMEA : A) MAL-FUNCTION OF THA (WEAR, FRACTURE, DISLOCATION ETC.) DUE TO WRONG SIZE OF HEAD DIAMETER AND/OR OFFSET, WRONG TAPER SIZE COMBINATION. B) MAL-FUNCTION OF THA (WEAR, FRACTURE, DISLOCATION ETC.) DUE TO OFF LABEL USE, COMBINATION WITH COMPETITOR PRODUCTS. COMPARISON TO INVESTIGATION RESULTS WHETHER IT IS POSSIBLE AND JUSTIFICATION: A) POSSIBLE AS NO POSTOPERATIVE X-RAYS ARE AVAILABLE AND THE CORRECT SIZING AND POSITIONING OF THE COMPONENTS. THEREFORE THIS POINT CANNOT BE EXCLUDED B) NOT POSSIBLE AS THE COMPATIBILITY OF THE PRODUCTS IS GIVEN. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. 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 LEFT SIDE AND UNDERWENT REVISION SURGERY DUE TO DISLOCATION.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES FOR REVIEW. SURGICAL REPORT WAS RECEIVED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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. THE REST OF THE PRODUCTS WERE REPORTED BY ZIMMER INC. (B)(4). ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A BIOLOX DELTA HEAD, 12/14, 32 X 0 ON THE LEFT SIDE ON (B)(6) 2015. THE PATIENT WAS TAKEN TO PACU WERE SUBLUXATED ANTERIORLY ON THE BED. THE PATIENT WAS BROUGHT BACK TO THE OR AND THE PRODUCTS WERE REVISED. FROM THE DESCRIBED EVENT, THE PRODUCT WAS IMPLANTED LESS THAN 24 HOURS IN THE PATIENT. THIS IS A SPLIT CASE WITH ZIMMER INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49443 BIOLOX DELTA HEAD, 12/14, 32 X 0 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER GMBH N/A 2806850

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R