BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVENIR MULLER, STEM, STANDARD, UNCEMENTED, HA, 1, TAPER 12/14

    MDR report key: 8045428 · Received November 7, 2018

    Report

    Report Number
    0009613350-2018-01130
    Event Type
    Malfunction
    Date Received
    November 7, 2018
    Date of Event
    October 9, 2018
    Report Date
    January 28, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024479456
    PMA / PMN Number
    K123392
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. ADDITIONAL: H2. CORRECTION: B4, D10, G4, G7, H3, H6, H10. DHR REVIEW: REF:01.06010.001 ; LOT: 2955599. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET. ALL REQUIREMENTS TO PERFORM AS INTENDED. THERE IS NEITHER A DHR NOR AN EXPIRATION DATE FOR STERILITY FOR REF. 01.06010.002 LOT. 2956599 AVAILABLE, AS THIS LOT HASN'T BEEN RELEASED YET. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: PRODUCT MIX-UP / WRONG LABELED PRODUCT. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT DURING A SURGERY AN AVENIR STEM SIZE 1 SHOULD BE IMPLANTED. THE PACKAGING AND DIVERSE LABELING WERE CORRECT. UPON INSERTING THE SHAFT IT WAS NOTICED THAT THE ENGRAVING ON THE CONE SHOWED SIZE 2 AND NOT SIZE 1. THE WRONG SIZE SHAFT WAS IN THE PACKAGING. PACKAGING LABELS SHOW: REF. 01.06010.001 LOT 2955599. SHAFT ENGRAVING SHOWS REF. 01.06010.002 LOT 2956599. REVIEW OF RECEIVED DATA: - THE RECEIVED PICTURES CONFIRM THAT THE LABELS ON THE PACKAGING DO NOT CORRESPOND TO THE DESCRIPTION ON THE STEM. DEVICES ANALYSIS: - COMPARING THE LABEL IDENTIFICATION TO THE DESCRIPTION OF THE LASER MARKING ON THE STEM CONFIRMS THAT THE LABELING IS NOT CORRECT, RESP. THE LABELS DO NOT CORRESPOND TO EACH OTHER. ALL LABELS ON THE OUTER BOX AND THE BAG SHOW: REF. 01.06010.001 LOT 2955599. ON THE CONE OF THE STEM FOLLOWING IDENTIFICATION IS LASER MARKED: REF. 01.06010.002 LOT 2956599. THUS THE ITEM NUMBER AND ALSO THE LOT NUMBER DO NOT MATCH. REVIEW OF PRODUCT DOCUMENTATION: - IN THE WAREHOUSE 5 PIECES OF THE PRODUCT ITEM# 01.06010.001, LOT# 2955599 WERE INSPECTED. ALL 5 STEMS WERE WRONGLY LABELED WITH "01.06010.002" AND "2956599". THE LABELED ITEM - LOT COMBINATION ALSO EXISTS IN THE DATABASE (MANUFACTURING DATE 13.07.2018), BUT HAS NEVER BEEN RELEASED (STATUS FROM 18-OCT-2018). CONCLUSION SUMMARY: IT WAS REPORTED THAT DURING A SURGERY AN AVENIR STEM SIZE 1 SHOULD BE IMPLANTED. THE PACKAGING AND DIVERSE LABELING WERE CORRECT. UPON INSERTING THE SHAFT IT WAS NOTICED THAT THE ENGRAVING ON THE CONE SHOWED SIZE 2 AND NOT SIZE 1. THE WRONG SIZE SHAFT WAS IN THE PACKAGING. PACKAGING LABELS SHOW: REF. 01.06010.001 LOT 2955599. SHAFT ENGRAVING SHOWS REF. 01.06010.002 LOT 2956599. CHECKING THE RETURNED PRODUCT SHOWED FOLLOWING RESULT: COMPARING THE LABEL IDENTIFICATION TO THE DESCRIPTION OF THE LASER MARKING ON THE STEM CONFIRMS THAT THE LABELING IS NOT CORRECT, RESP. THE LABELS DO NOT CORRESPOND TO EACH OTHER. ALL LABELS ON THE OUTER BOX AND THE BAG SHOW: REF. 01.06010.001 LOT 2955599. ON THE CONE OF THE STEM FOLLOWING IDENTIFICATION IS LASER MARKED: REF. 01.06010.002 LOT 2956599. THUS THE ITEM NUMBER AND ALSO THE LOT NUMBER DO NOT MATCH. TO CHECK IF POTENTIALLY THE WHOLE LOT IS AFFECTED, THE WAREHOUSE OPENED AND INSPECTED 5 PIECES OF THE PRODUCT ITEM# 01.06010.001, LOT# 2955599. ALL 5 STEMS WERE WRONGLY LABELED WITH "01.06010.002" AND "2956599". BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION IT CAN BE CONCLUDED THAT WHILE MANUFACTURING THE AVENIR STEMS A COMMINGLE OCCURRED. BASED ON THE AVAILABLE INFORMATION FURTHER INVESTIGATION HAS BEEN INITIATED TO DETERMINE THE NECESSITY OF POTENTIAL CORRECTIVE AND/OR PREVENTIVE ACTIONS. A RECALL HAS BEEN CONDUCTED (AFFECTED CLINICS IN GERMANY AND SWITZERLAND, USA NOT AFFECTED). ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    NO EVENT UPDATE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATE DETAIL OF PRODUCT: ITEM #: 0106010002, ITEM NAME: AVENIR MULLER, STEM, STANDARD, UNCEMENTED, HA, 2, TAPER 12/14, LOT / #: 2956599. THE MANUFACTURER DID NOT RECEIVE X-RAYS BUT RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY THE ENGRAVING ON THE CONE SHOWED A DIFFERENT SIZE FROM THE ONE SHOWN ON THE PACKAGE. THE WRONG SIZE SHAFT WAS IN THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889095 AVENIR MULLER, STEM, STANDARD, UNCEMENTED, HA, 1, TAPER 12/14 AVENIR MULLER STEM LZO ZIMMER GMBH N/A 2955599 00889024479456

    Patients

    Seq Age Sex Outcome Treatment
    1 REFER TO H10