BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 40MM

    MDR report key: 10332404 · Received July 28, 2020

    Report

    Report Number
    3002806535-2020-00336
    Event Type
    Injury
    Date Received
    July 28, 2020
    Date of Event
    June 11, 2020
    Report Date
    December 17, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    OQG
    PMA / PMN Number
    K082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00337-1. PRODUCT HAS BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO A RESEARCH ENGINEER FOR INVESTIGATION. A BIOLOX DELTA OPTION FEMORAL HEAD AND A G7 HI-WALL E1 LINER WERE REVISED AFTER THE LINER DISASSOCIATED FROM THE ACETABULAR SHELL AFTER APPROXIMATELY 3 MONTHS AND A HALF IN USE. THE AVAILABLE RELEVANT MANUFACTURING HISTORY RECORD INDICATE THAT THE ITEMS WERE MANUFACTURED IN ACCORDANCE WITH THE APPLICABLE SPECIFICATIONS. VISUAL INSPECTION OF THE CERAMIC HEAD SHOWED A LARGE METAL TRANSFER PATCH ON ITS BEARING SURFACE, CONSISTENT WITH THE REPORTED LINER DISASSOCIATION AND METALLOSIS DESCRIBED IN THE PROVIDED SURGICAL NOTES. VISUAL INSPECTION OF THE G7 HI-WALL E1 LINER SHOWED EXTENSIVE DAMAGE, AS WELL AS SOME SCRATCHES TO THE BEARING SURFACE, AROUND THE REGION OF THE HIGH WALL, ALSO CONSISTENT WITH THE REPORTED DISASSEMBLY OF THE COMPONENT FORM THE ACETABULAR SHELL. THE PROVIDED SURGICAL NOTES STATE THAT THE ACETABULAR POLYETHYLENE LINER EXHIBITED WEAR PATTERN ASSOCIATED WITH MALPOSITION AND INAPPROPRIATE WEIGHT DISTRIBUTION. OTHER FACTORS THAT MAY HAVE CONTRIBUTED TO THE EARLY FAILURE OF THE IMPLANT CANNOT BE DISCUSSED WITHOUT PROVISION OF THE REQUESTED RADIOGRAPHS. THE AVAILABLE MHR REVIEWS INDICATE THAT THE PRODUCTS WERE MOST LIKELY CONFORMING TO DESIGN SPECIFICATION WHEN THEY LEFT ZIMMER BIOMET CONTROL. RISK ASSESSMENT: RISK MANAGEMENT REPORT DOCUMENTS THE ESTIMATED RESIDUAL RISK ASSOCIATED WITH THE REPORTED EVENT. THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED WITH THE INFORMATION CURRENTLY AVAILABLE, THEREFORE THE SPECIFIC FAILURE CAUSE WITHIN THE RISK TABLES COULD NOT BE SELECTED FOR COMPARISON. THE REPORTED EVENT STATES REVISION DUE TO DISLOCATION. IN THE RISK FILE, DISLOCATION IS CONSIDERED HARM WITH A SEVERITY LEVEL OF 3 FOR A NUMBER OF HAZARDS DEFINED AS MODERATE, WHICH IS DESCRIBED IN THE SEVERITY TABLE AS: S-3 PRESCRIBED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR BODY STRUCTURE. CONTRIBUTED TO MINOR, TEMPORARY, OR MEDICALLY REVERSIBLE INJURY. THE OUTCOME OF THE REPORTED EVENT (SURGICAL INTERVENTION) IS CONSIDERED TO BE WITHIN THE SEVERITY OF THE RMF. NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO POLY LINER DETACHMENT FROM CUP. DURING THE PROCEDURE, THE HEAD WAS NOTED TO HAVE ARTICULATED ON THE METAL CUP, SO BOTH THE HEAD AND LINER COMPONENTS WERE REMOVED AND REPLACED. PATIENT EXPERIENCED DISCOMFORT AND RESTRICTED DAILY ACTIVITIES.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL MDR REPORT. CUSTOMER HAS INDICATED THAT THE PRODUCT IS AVAILABLE TO BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. MEDICAL PRODUCT: CER OPTION TYPE 1 TPR SLEVE -3, CATALOG #: 650-1065, LOT #: 2936757. MEDICAL PRODUCT: G7 HI-WALL E1 LINER 40MM F, CATALOG #: 010000942, LOT #: 6592120. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00337. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO POLY LINER DETACHMENT FROM CUP. DURING THE PROCEDURE, THE HEAD WAS NOTED TO HAVE ARTICULATED ON THE METAL CUP, SO BOTH THE HEAD AND LINER COMPONENTS WERE REMOVED AND REPLACED. PATIENT EXPERIENCED DISCOMFORT AND RESTRICTED DAILY ACTIVITIES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794950 CER BIOLOXD OPTION HD 40MM CERAMIC FEMORAL HEAD PROSTHESIS OQG BIOMET UK LTD. N/A 2957976

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R