BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA CERAMIC FEMORAL HEAD, M 36/0, TAPER 12/14

    MDR report key: 9652435 · Received January 31, 2020

    Report

    Report Number
    0009613350-2020-00036
    Event Type
    Injury
    Date Received
    January 31, 2020
    Date of Event
    January 9, 2020
    Report Date
    April 27, 2020
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024430365
    PMA / PMN Number
    K071535
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT SUMMARY: IT WAS REPORTED THAT THE PRODUCT WAS IMPLANTED ON (B)(6) 2019 AND UNDERWENT REVISION ON (B)(6) 2020 DUE TO DISLOCATION. PATIENT HAD TWO DISLOCATION PRIOR TO REVISON, THE SECOND ONE BEING AS A RESULT OF GARDENING. THE HEAD AND THE LINER WERE REMOVED. REVIEW OF RECEIVED DATA: MEDICAL RECORDS AND RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE MEDICAL RECORDS IDENTIFIED THE FOLLOWING: THE PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2019 DURING WHICH ZIMMER BIOMET PRODUCTS WERE IMPLANTED WITHOUT COMPLICATIONS. THE PATIENT DISLOCATED TWICE AND WAS REVISED ON (B)(6) 2020. REVISION OPERATIVE NOTES WERE NOT PROVIDED. REVIEW OF THE RADIOGRAPHS IDENTIFIED THE FOLLOWING: ASSESSMENT OF IMAGING: AP PELVIS FILM DEMONSTRATES BILATERAL TOTAL HIP ARTHROPLASTIES WITH CEMENT FIXATION OF THE ACETABULAR CUPS BILATERALLY. NO RADIOLUCENCY ALONG THE LEFT ACETABULAR CUP OR FEMORAL STEM. NO ACUTE FRACTURE. SYMPHYSIS PUBIS DEGENERATIVE CHANGE. HETEROTOPIC OSSIFICATION ALONG THE RIGHT GREATER TROCHANTER. NO SIGNS OF LOOSENING, WEAR OR RADIOLUCENCY OVERALL FIT AND ALIGNMENT OF THE IMPLANTS IS APPROPRIATE. NORMAL BONE QUALITY. ACETABULAR INCLINATION ANGLE ON THE LEFT: 40° IMPRESSIONS: BILATERAL TOTAL HIP ARTHROPLASTIES WITHOUT HARDWARE FAILURE OR LOOSENING. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION THIS DEVICE IS INTENDED FOR TREATMENT. DHR REVIEW: THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. CONCLUSION SUMMARY : IT WAS REPORTED THAT THE PRODUCT WAS IMPLANTED ON (B)(6) 2019 AND UNDERWENT REVISION ON (B)(6) 2020 DUE TO DISLOCATION. PATIENT HAD TWO DISLOCATION PRIOR TO REVISON, THE SECOND ONE BEING AS A RESULT OF GARDENING. THE HEAD AND THE LINER WERE REMOVED. THE REVIEW OF THE X-RAYS DID NOT IDENTIFY ANY COMPLICATIONS SUCH AS PRODUCT PLACEMENT OR PATIENT ANATOMY THAT WOULD CONTRIBUTE TO RECURRENT DISLOCATIONS. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THERFORE, THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). THE REASONS FOR HIP DISLOCATION ARE MULTIFACTORIAL, WITH CONTRIBUTING FACTORS FROM THE PATIENT, THE IMPLANT, AND THE SURGICAL PROCEDURE. POSSIBLE ROOT CAUSES INCLUDE WRONG HEAD OFFSET CHOICE, INADEQUATE ASSEMBLING PROCEDURE, HIGH PATIENT ACITIVITY, INADEQUATE INFORMATION DURING PATIENTS COUNSELING BY SURGEON LEADING TO PREMATURE FAILURE CAUSED BY PATIENT BEHAVIOUR, PATIENT DISREGARDING THE LIMITS OF THE DEVICE OR JOINT LAXITY. BASED ON THE AVAILABLE INFORMATION, AN EXACT ROOT CAUSE FOR THE DISLOCATIONS COULD NOT 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

    MEDICAL PRODUCT: LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS; PART#00630505036; LOT#64137415, PALACOS CEMENT PART#66044274; LOT#H106, SHELL POROUS WITH CLUSTER HOLES 52 MM O.D. WITH CALCICOAT CERAMIC COATING; PART#65620005222; LOT#63834567, FEMORAL STEM 12/14 NECK TAPER STD. OFFSET SIZE 2 130 MM STEM LENGTH; PART#00811400200; LOT#63629352. THERAPY DATE: (B)(6) 2020. X-RAYS, SURGICAL REPORTS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE LOT NUMBER OF THE DEVICE WAS RECEIVED. THE DEVICE HISTORY RECORDS WILL BE REVIEWED DURING INVESTIGATION. 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 · 1

    IT WAS REPORTED THAT PATIENT WAS IMPLANTED ON THE LEFT SIDE AND UNDERWENT REVISION DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118921 BIOLOX DELTA CERAMIC FEMORAL HEAD, M 36/0, TAPER 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER GMBH N/A 2976746 00889024430365

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R