BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOLOX HEAD

    MDR report key: 7265899 · Received February 13, 2018

    Report

    Report Number
    0009613350-2018-00232
    Event Type
    Injury
    Date Received
    February 13, 2018
    Date of Event
    August 9, 2017
    Report Date
    February 13, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(6). AS THERE IS NO ITEM# AVAILABLE IT IS NOT CLEAR IFIT IS CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(6) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K071535. NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: DISASSOCIATION. DEVICE HISTORY RECORDS (DHR): THE DHR CHECK COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. EVENT SUMMARY: IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A UNKNOWN BIOLOX HEAD AND UNKNOWN LINER AND REVISED ON (B)(6) 2017 DUE TO LOOSENING OF THE CUP ((B)(6)) AND LINER DISASSOCIATION. (B)(6) SPLIT CASE FOR SHELL AND SCREWS IS REPORTED IN (B)(4). REVIEW OF RECEIVED DATA: THERE IS ONE X-RAY AVAILABLE. THE X-RAY WAS REVIEWED IN COMPLAINT (B)(4) ((B)(6)). THE REVIEW WAS DONE BY AN EXTERNAL SURGEON. SEE COMPLAINT (B)(4) ((B)(6)). RIGHT TOTAL HIP ARTHROPLASTY DEMONSTRATES EXTENSIVE SCREW FIXATION OF THE ACETABULAR CUP WITH A PROVIDED POSITION OF THE LEFT FEMORAL HEAD. THERE IS NO EVIDENCE FOR BONE SURROUNDING THE FEMORAL STEM AND A FRACTURE PRESUMED CERCLAGE WIRE WITHIN THE SOFT TISSUES. THE LEFT ACETABULAR CUP IS IN APPROPRIATE POSITION ALTHOUGH THERE IS BONY RESORPTION ALONG THE INFERIOR ASPECT OF THE ACETABULAR CUP WITH INFERIOR MOST SCREW EXTENDING INTO THE SOFT TISSUES RATHER THAN BONE AS WELL AS A FRACTURED SCREW IN THIS REGION. SUPERIOR DISLOCATION OF THE LEFT FEMORAL HEAD WITH RESPECT TO THE ACETABULAR CUP. THERE IS EVIDENCE OF SUPERIOR DISLOCATION OF THE LEFT FEMORAL HEAD WITH RESPECT TO THE ACETABULAR CUP. LUCENCY SURROUNDING THE LEFT FEMORAL STEM WITH SCLEROTIC MARGIN SUGGESTS POSSIBLE OSTEOLYSIS WHICH CAN ALSO SUGGEST LOOSENING. ADDITIONALLY, THERE IS EVIDENCE OF LEFT INFERIOR PUBIC RAMUS FRACTURE AS WELL AS FRACTURE ALONG THE MEDIAL WALL OF THE RIGHT ACETABULUM. POSSIBLE LEFT INFERIOR PUBIC RAMUS FRACTURE AND FRACTURE INVOLVING THE MEDIAL ASPECT OF THE LEFT ILIAC WING. OSTEOPENIA DOES LIMIT EVALUATION FOR FRACTURE. A PICTURE WAS PROVIDED WHICH SHOWS THE EXPLANTED IMPLANTS. THE EXPLANTED LINER, SHELL AND HEAD ARE PROVIDED. THE EXPLANTS IN THE PHOTOGRAPH DISPLAY WEAR AND TEAR FROM DISASSOCIATION OF LINER AND HEAD ARTICULATING AGAINST THE SHELL. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS, THE PRODUCT LOCATION IS UNCLEAR. ROOT CAUSE ANALYSIS: THE REVIEW OF THE X-RAY SHOWED THAT THE LINER WAS DISASSOCIATED FROM THE SHELL. THEREFORE, THE DFMEA OF THE LINER AND ALSO THE DFMEA OF THE SHELL (WARSAW) WERE CONSIDERED FOR THE ROOT CAUSE ANALYSIS. ROOT CAUSE DETERMINATION USING DFMEA (LINER): WEAR TO HEAD OR LINER DUE TO SURGEON DOES NOT FOLLOW SURGICAL TECHNIQUE => POSSIBLE: AS NO DETAILED INFORMATION LIKE SURGICAL REPORT OR OTHER RELEVANT DOCUMENTS WERE PROVIDED, IT IS POSSIBLE THAT THE SURGEON DID NOT FOLLOW THE TECHNIQUE. ROOT CAUSE DETERMINATION USING DFMEA CUP: DISSOCIATION OF CERAMIC LINER FROM SHELL DUE TO LOCKING MECHANISM FAILS TO SECURE LINER DUE TO INADEQUATE DESIGN (AXIALLY ALIGNED LINER) => NOT POSSIBLE: A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. CONCLUSION SUMMARY: IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH AN UNKNOWN BIOLOX HEAD AND UNKNOWN LINER AND REVISED ON (B)(6) 2017 DUE TO LOOSENING OF THE CUP (WARSAW) AND LINER DISASSOCIATION. THE (B)(6) SPLIT CASE FOR SHELL AND SCREWS IS REPORTED IN (B)(4). AN X-RAY WAS RECEIVED WHICH WAS REVIEWED BY AN EXTERNAL SURGEON IN (B)(6)'S COMPLAINT. THE DISASSOCIATION OF THE LINER FROM THE SHELL AND THE DISLOCATION OF THE BIOLOX HEAD WERE CONFIRMED BY THE SURGEON. AS A RESULT OF THE DISASSOCIATION BETWEEN LINER AND SHELL, THE BIOLOX HEAD WAS DISLOCATED. THE EXPLANTS IN THE PHOTOGRAPH DISPLAY WEAR AND TEAR FROM DISASSOCIATION OF LINER AND HEAD ARTICULATING AGAINST THE SHELL. THE DEVICES HAVE NOT BEEN RETURNED FOR INVESTIGATION. NO SPECIFIC PATIENT INFORMATION WAS RECEIVED FOR EVALUATION. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THE DISASSOCIATION OF THE LINER FROM THE SHELL. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION PROCEDURE DUE TO LOOSENING OF CUP AND DISASSOCIATION OF LINER. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110731 UNKNOWN BIOLOX HEAD LZO ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R BIOLOX LINER, ITEM# 00877501236, LOT# UNKNOWN