BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOLOX OPTION, HEAD, M¸ 32/0, TAPER 8/10

    MDR report key: 5690612 · Received June 1, 2016

    Report

    Report Number
    0009613350-2016-00805
    Event Type
    Malfunction
    Date Received
    June 1, 2016
    Report Date
    May 10, 2016
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE DEVICES FOR INVESTIGATION. ONE PICTURE OF THE PACKAGES WAS RECEIVED. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICE, THE DEVICE HISTORY RECORD WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL REPORT WILL BE SUBMITTED. THE ACTUAL DEVICE REPORTED IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (REF. 00-8777-028-02 BIOLOX OPTION HD/ APT, 12/14, 28X0) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    TREND ANALYSIS: A TREND HAS BEEN IDENTIFIED FOR ITEM NUMBER 00-8778-032-02 AND LOT 2844242. AS AN IMMEDIATE ACTION, ZIMMER BIOMET BLOCKED THE SHIPPING OF THE AFFECTED LOT 2844242 TO ITS CUSTOMERS, TO PREVENT FURTHER DISTRIBUTION OF THE DEVICES IN THE FIELD. AN ISSUE INVESTIGATION HAS BEEN PERFORMED AND RESULTS ARE PRESENTED BELOW. DEVICE HISTORY RECORDS (DHR): THE DHR REVIEW SHOWED THAT THE PRODUCTS ARE ACCORDING TO THE DRAWING SPECIFICATIONS. THE DHR CHECK OF THE LOT 2844242 SHOWS THAT THE TAPER SIZE DESCRIPTION ON THE LABELS IS WRONG, IT SHOULD BE "TAPER 8/10" AND IS ACTUALLY "TAPER 12/14". REVIEW OF EVENT DESCRIPTION: THE PRODUCT DESCRIPTION ON THE LABELS CONTAINS INCORRECT INFORMATION. FOR THE MATERIAL 00-8778-032-02 BATCH: 2844242 THE PRODUCT DESCRIPTION SHOULD BE BIOLOX OPTION, HEAD, M, Ø 32/10, TAPER 8/10 BUT IT IS ACTUALLY LABELED AS BIOLOX OPTION, HEAD, M, Ø 32/10, TAPER 12/14. INCONSISTENCY ERRONEOUS INFORMATION ON THE TAPER DIAMETER ON THE LABEL IS APPARENT (INCORRECT PATIENT-, PRODUCT- AND BARCODE-LABEL). REVIEW OF RECEIVED DATA: ONE PICTURE WITH 3 PRODUCTS (3 LABELS) WAS RECEIVED. THE QUALITY IS VERY POOR AND THE INDICATION OF THE TAPER SIZE IS NOT READABLE. IT CAN HOWEVER BE SEEN THAT ALL 3 LABELS HAVE THE SAME REF NUMBER BUT DIFFERENT LABELS. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. WITHIN THE ISSUE INVESTIGATION, A PRODUCT FROM THE LOT 2844242 WAS TAKEN FROM THE WAREHOUSE. THE PACKAGING WAS OPENED AND THE PRODUCT INSIDE THE PACKAGING WAS A BIOLOX@ OPTION, HEAD, M, Ø 32/10, TAPER 8/10 AND IS CORRECTLY MARKED. THE DHR REVIEW SHOWED THAT THE PRODUCTS ARE ACCORDING TO THE DRAWING SPECIFICATIONS. WE CAN CONSIDER THAT ONLY THE TAPER INFORMATION ON THE LABEL IS INCORRECT. AN ADDITIONAL BARCODE SCANTEST SHOWED THAT THE BARCODE ON THE LABELS CONTAIN THE CORRECT PRODUCT INFORMATION BEHIND. IT WAS FOUND THAT DURING A REVISION OF THE LABEL IN THE DATABASE, THE PRODUCT DESCRIPTION WAS ERRONEOUSLY TRANSFERRED, RESULTING IN A WRONG TAPER SIZE MENTIONED. THE ISSUE IS RELATED TO PRODUCTS MANUFACTURED AND LABELED AFTER SEPTEMBER 22, 2015. ONLY ONE MATERIAL-BATCH COMBINATION WAS MANUFACTURED OVER THE TIME. PRODUCT FAMILY FROM BIOLOX OPTION HEADS LABELS WERE CHECKED REGARDING INCORRECT PRODUCT DESCRIPTION AND INCORRECT TAPER SIZE DESCRIPTION IN THE DATABASE. ONLY THIS MATERIAL WITH THE REFERENCE 00-8778-032-02 WAS DETECTED AND MISLABELED. FURTHERMORE, ALL POTENTIALLY AFFECTED OTHER MATERIALS WITH A SIMILAR SET-UP OF LABEL INFORMATION WERE CHECKED (IN TOTAL 749 MATERIALS). IT WAS CONCLUDED THAT ALL INSPECTED MATERIALS ARE LABELED CORRECTLY WITH THE CURRENTLY RELEASED LABEL VERSION. AN URGENT FIELD SAFETY NOTICE REMOVAL WAS SENT TO THE AFFECTED HOSPITALS AND SURGEONS ON JUNE 09, 2016 (ONE AFFECTED COUNTRY ONLY: (B)(6)). THIS ACTION WAS A VOLUNTARY REMOVAL OF THE AFFECTED SINGLE LOT OF BIOLOX OPTION HEAD/ ADAPTOR, TAPER SIZE 8/10. A CHANGE PROJECT WAS PERFORMED TO CORRECT THE WRONG LABEL. THE NEW VERSION FOR THE LABEL 00-8778-032-02 BIOLOX HEAD WAS RELEASED ON JULY 17TH, 2016. AN EXACT ROOT CAUSE COULD BE DETERMINED. DURING A REVISION OF THE LABEL IN THE DATABASE, THE PRODUCT DESCRIPTION WAS ERRONEOUSLY TRANSFERRED, RESULTING IN A WRONG TAPER SIZE MENTIONED. A FIELD ACTION HAS BEEN CONDUCTED TO PREVENT ANY FURTHER ISSUE. THIS LOT HAS NOT BEEN DISTRIBUTED TO USA, THEREFORE NO FIELD ACTION REPORTED TO FDA. ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE LABELS OF THE BIOLOX OPTION HD/ADPT, ARE INCORRECT. THE PRODUCTS INDICATES THAT THE SAME REFERENCE: (B)(4) FOR DIFFERENT PRODUCTS: BIOLOX OPTION HD/ADPT, 8/10, 32 X 0. BIOLOX OPTION HD/ADPT, 12/14, 32 X 0. IT IS INDEED THE REFERENCE OF THE BIOLOX OPTION HD/ADPT, 8/10, 32 X 0 BUT FOR THE SECOND PRODUCT THE REAL REFERENCE IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346356 BIOLOX OPTION, HEAD, M¸ 32/0, TAPER 8/10 BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES LZO ZIMMER GMBH N/A 2844242

    Patients

    Seq Age Sex Outcome Treatment
    1