BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 36/+3.5, TAPER 12/14

    MDR report key: 7193540 · Received January 16, 2018

    Report

    Report Number
    0009613350-2018-00100
    Event Type
    Injury
    Date Received
    January 16, 2018
    Date of Event
    December 17, 2017
    Report Date
    August 10, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    PK071535
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORDS (DHR): 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: PAIN REVIEW OF EVENT DESCRIPION: IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT DIRECT ANTERIOR TOTAL HIP ARTHROPLASTY WITH COMPUTER NAVIGATION ON DEC EMBER4, 2013. THE PATIENT IS A SUBJECT IN THE VIVACIT-E CLINICAL STUDY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN IN HIP APPROX. 4 YEARS POST-OPERATIVE (REPORTED ON DECEMBER 17, 2017). A MEDICAL INTERVENTION TO TREAT THE HIP PAIN CONSISTED OF T3, SULINAC, BLOOD WORK AND A BONE SCAN TO RULE OUT INFECTION OR MECHANICAL LOOSENING. THE INITIAL OPERATIVE REPORT OF THE THA STATES THAT THERE WERE NO COMPLICATIONS. THE FOLLOWING PRODUCTS WERE IMPLANTED DURING THA: - 00-8775-036-03 BIOLOX DELTA HEAD 12/14 36X+3.5 - 00-8757-056-01 CONTINUUM TM SHELL 56KK (SEE WARSAW SPLIT-CASE CMP-0359380, 0001822565 - 2018 - 00319) - 00-8851-012-36 VIT E LINER NEUTRAL KK36 (SEE WARSAW SPLIT-CASE CMP-0359380, 0001822565 - 2018 - 00320) - 00-7711-012-20 M/L TAPER SIZE 2.5 EXTENDED OFFSET (SEE WARSAW SPLIT-CASE CMP-0359380, 0001822565-2018-00321) REVIEW OF RECEIVED DATA: - INITIAL OP NOTES DATED DECEMBER 4, 2018: ACCORDING TO THE SURGICAL REPORT THE PATIENT UNDERWENT A RIGHT DIRECT ANTERIOR TOTAL HIP ARTHROPLASTY WITH COMPUTER NAVIGATION ON DECEMBER 4, 2013 DUE TO PREOPERATIVE DIAGNOSIS OF RIGHT HIP DEGENERATIVE JOINT DISEASE. NO NOTED COMPLICATIONS. - THREE X-RAYS (AP PELVIS, AP FILM ON THE RIGHT HIP, AND FROG LEG VIEW OF THE RIGHT HIP, UNDATED) HAVE BEEN RECEIVED. THE X-RAY ASSESSMENT WAS PERFORMED BY A RADIOLOGIST ON JANUARY 18, 2018, SEE SPLIT CASE CMP-0359380. RIGHT TOTAL HIP ARTHROPLASTY WITHOUT DEFINITE HARDWARE FAILURE OR LOOSENING. EXTENSIVE HETEROTOPIC OSSIFICATION ARISING FROM THE LESSER TROCHANTER, GREATER TROCHANTER OF THE RIGHT FEMUR AS WELL AS THE ANTERIOR INFERIOR ILIAC SPINE OF THE RIGHT PELVIS. HETEROTOPIC OSSIFICATION ALSO SEEN ALONG THE FEMORAL ACETABULAR JOINT. EARLY BONY BRIDGING IS PRESENT BOTH SUPERIOR AND INFERIOR TO THE JOINT SPACE. THE OVERALL FIT AND ALIGNMENT OF THE RIGHT TOTAL HIP ARTHROPLASTY IS WITHIN NORMAL LIMITS. NORMAL BONE MINERALIZATION IS PRESENT. EXTENSIVE HETEROTOPIC OSSIFICATION SURROUNDING THE RIGHT HIP AND RIGHT PELVIS WITH NEAR VERSUS EARLY BONY BRIDGING IS SEEN. THE EXTENSIVE HETEROTOPIC OSSIFICATION OF THE RIGHT HIP LIKELY CONTRIBUTES TO THE PATIENT'S PAIN AS THERE IS EARLY VERSUS NEAR BONY BRIDGING PRESENT. THERE IS NO EVIDENCE FOR LOOSENING OR FAILURE OF THE RIGHT TOTAL HIP ARTHROPLASTY OTHERWISE SEEN. DEVICES ANALYSIS: PRODUCT REMAINS IMPLANTED. REVIEW OF PRODUCT DOCUMENTATION: - THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS: PAIN CANNOT BE RELATED TO A SINGLE SPECIFIC FAILURE MODE. THEREFORE, BASED ON THE GIVEN INFORMATION A SPECIFIC ROOT CAUSE ANALYSIS IS NOT POSSIBLE. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, THE CASE WILL BE RE-EVALUATED. ALL POSSIBLE ROOT CAUSES FOR THIS PRODUCT CAN BE FOUND IN THE RISK MANAGEMENT WORKSHEET. CONCLUSION SUMMARY: BASED ON THE GIVEN INFORMATION AND THE DOCUMENTS RECEIVED THE COMPLAINT COULD NOT BE RECREATED. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. FURTHER, THE X-RAY ASSESSMENT, PERFORMED BY A RADIOLOGIST, DOES NOT INDICATE ANY MALFUNCTIONING OF THE IMPLANT, AS THERE IS NO EVIDENCE FOR INFECTION, MECHANICAL LOOSENING OR FAILURE OF THE RIGHT TOTAL HIP ARTHROPLASTY OTHERWISE SEEN ON THE X-RAYS. THE EXTENSIVE HETEROTOPIC OSSIFICATION OF THE RIGHT HIP LIKELY CONTRIBUTES TO THE PATIENT'S PAIN AS THERE IS EARLY VERSUS NEAR BONY BRIDGING PRESENT. THEREFORE, BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THE REPORTED HIP PAIN, HOWEVER, THE PRESENT HETEROTOPIC OSSIFICATION IS A LIKELY CAUSE OF PAIN. 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 CMP-0359958.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. SURGICAL REPORT WAS RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. 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

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 36/+3.5, TAPER 12/14 ON THE RIGHT SIDE ON (B)(6) 2013. CURRENTLY, THE PATIENT IS EXPERIENCING PAIN AND TREATED WITH SULINDAC, BLOOD WORK, BONE SCAN TO RULE OUT INFECTION OR MECHANICAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39474 BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 36/+3.5, TAPER 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER GMBH N/A 2712175

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R