BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX OPTION, HEAD, XL, 32/+7, TAPER 12/14

    MDR report key: 11957552 · Received June 8, 2021

    Report

    Report Number
    0009613350-2021-00264
    Event Type
    Injury
    Date Received
    June 8, 2021
    Report Date
    October 7, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    UDI-DI
    00889024430501
    PMA / PMN Number
    K073567
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. ADDITIONAL: H2, H6 CORRECTION: B4, B5, G3, G6, H10. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY PERFORMED ON (B)(6) 2009 AND UNDERWENT REVISION SURGERY ON (B)(6) 2019. AFTER REVISION SURGERY PATIENT CONTINUES TO HAVE PAIN, WEAKNESS, AND GAIT IMPAIRMENT REQUIRING USE OF A CANE WHILE AMBULATING. REVIEW OF RECEIVED DATA: NO MEDICAL DATA RELEVANT TO THE CASE HAS BEEN RECEIVED. DUE DILIGENCE: NO FURTHER "DUE DILIGENCE" REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. PRODUCT EVALUATION: THE BIOLOX HEAD REMAINS IMPLANTED; THEREFORE, THE PRODUCT EVALUATION COULD NOT BE PERFORMED. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. CONCLUSION: IT WAS REPORTED THAT THE PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY PERFORMED ON (B)(6) 2009 AND UNDERWENT REVISION SURGERY ON (B)(6) 2019. AFTER REVISION SURGERY PATIENT CONTINUES TO HAVE PAIN, WEAKNESS, AND GAIT IMPAIRMENT REQUIRING USE OF A CANE WHILE AMBULATING. THE DEVICE REMAINS IMPLANTED. MEDICAL RECORDS OF THE REPORTED PAIN AND DIFFICULTY IN WALKING FOLLOWING THE REVISION SURGERY ARE NOT AVAILABLE. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, THE INVESTIGATION DID NOT IDENTIFY A NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). BASED ON THE PROVIDED INFORMATION THE REPORTED EVENT CANNOT BE CONFIRMED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCTS: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 13.5 STANDARD OFFSET; CATALOG#: 00-7711-013-00; LOT#: 61118280. SHELL POROUS WITH CLUSTER HOLES 48 MM; CATALOG#: 00-6202-048-22; LOT#: 61210891. LINER 20 DEGREE ELEVATED RIM 32 MM I.D. FOR USE WITH 48 MM O.D. SHELL; CATALOG#: 00-6320-048-32; LOT#: 64079878. BONE SCREW SELF-TAPPING 6.5 MM DIA. 40 MM LENGTH; CATALOG#: 00-6250-065-40; LOT#: 63556534. THERAPY DATE: UNKNOWN. THE MANUFACTURER RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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

    PATIENT RECEIVED INITIAL TOTAL HIP ARTHROPLASTY ON THE RIGHT SIDE AND UNDERWENT REVISION SURGERY DUE TO PAIN, METAL RELATED PATHOLOGY AND A FRACTURED POLY. AFTER REVISION SURGERY PATIENT CONTINUOUS TO EXPERIENCE PAIN, WEAKNESS AND GAIT IMPAIRMENT REQUIRING USE OF CANE WHILE AMBULATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859967 BIOLOX OPTION, HEAD, XL, 32/+7, TAPER 12/14 BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2931440 00889024430501

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization SEE H10 NARRATIVE.