BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVENIR MÜLLER, STEM, STANDARD, UNCEMENTED, HA, 3, TAPER 12/14

    MDR report key: 7103595 · Received December 11, 2017

    Report

    Report Number
    0009613350-2017-01714
    Event Type
    Malfunction
    Date Received
    December 11, 2017
    Date of Event
    November 13, 2017
    Report Date
    April 9, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    PK123392
    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. AVENIR MUELLER, STEM, LATERAL, UNCEMENTED, HA, 4, TAPER 12/14, ITEM#: 01.06010.104, LOT#: 2905496 (STEM IMPLANTED). TREND ANALAYSIS: A TREND CONSIDERING THE FOLLOWING EVENT WAS IDENTIFIED: WRONG (OR MISSING) LABEL IN THE PACKAGING. 2 SIMILAR INVESTIGATED EVENTS FOR THE LOT NUMBER: 2905496 HAVE BEEN FOUND. THE FOLLOWING COMPLAINTS ARE CONSIDERED: (B)(4) (CASE AT HANDS, WRONG LABEL INSIDE THE PACKAGING). (B)(4) (ISSUE RELATED TO A MISSING LABEL INSIDE THE PACKAGING). AN ISSUE EVALUATION HAS BEEN PERFORMED (SEE BELOW). DEVICE HISTORY RECORDS (DHR): PATIENT LABEL: LOT#: 2905496, REF#: (B)(4). THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. PACKAGING LABEL: LOT#: 2904368, REF#: (B)(4). THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT AFTER A SURGERY (WHEN RE-ORDERING PRODUCT) IT WAS DETECTED THAT THE PATIENT LABEL WHICH CAN BE FOUND INSIDE THE AVENIR PACKAGING DID NOT CORRESPOND WITH THE LABEL ON THE OUTSIDE OF THE PACKAGING. REVIEW OF RECEIVED DATA: TWO X-RAYS OF THE IMPLANTED STEM HAVE BEEN RECEIVED. THE IMPLANTED STEM WAS ASSESSED WITH COMPARING THE X-RAYS TO THE APPLICABLE DRAWINGS OF BOTH STEMS. IT COULD BE DETERMINED THAT ITEM#: 01.06010.104 (LOT: 2905496) WAS IMPLANTED (AVENIR SIZE 4 LATERAL). DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET. THE STEM IS STILL IMPLANTED. IT WAS REPORTED THAT THE PACKAGING WAS DISCARDED BY THE HOSPITAL. REVIEW OF PRODUCT DOCUMENTATION: IT WAS REPORTED THAT THE INNER AND OUTER LABEL DOES NOT CORRESPOND TO EACH OTHER. THE INNER AND OUTER LABELS ARE NOT CONGRUENT AND GIVE DIFFERENT INFORMATION ABOUT THE SIZES AND SHAPE ("STANDARD" VERSUS "LATERAL") OF THE CONTENT OF THE PACKAGE. ITEM#: 01.06010.104, LOT: 2905496: MANUFACTURING DATE 19.04.2017. ITEM#: 01.06010.003, LOT: 2904368: MANUFACTURING DATE 13.04.2017. IT WAS REPORTED THAT AFTER A SURGERY THE PATIENT LABEL WHICH CAN BE FOUND INSIDE THE AVENIR PACKAGING DID NOT CORRESPOND WITH THE LABEL ON THE OUTSIDE OF THE PACKAGING. THE TWO RECEIVED X-RAYS OF THE IMPLANTED STEM HAVE BEEN ASSESSED. COMPARING THE X-RAYS TO THE APPLICABLE DRAWINGS IT COULD BE DETERMINED THAT THE AVENIR MÜLLER STEM 4 LATERAL WITH ITEM NUMBER: 01.06010.104 (LOT: 2905496) WAS IMPLANTED. AN ISSUE EVALUATION HAS BEEN PERFORMED. THE PURCHASE ORDERS WERE REVIEWED. 2 PURCHASE ORDERS WERE APPLICABLE: PURCHASE ORDER (PO) 4501738614 ON 28.04.2017 INCLUDED 39 PIECES OF SIZE 3 (01.06010.003, LOT#: 2904368). 39 DEVICES HAVE BEEN DELIVERED. PURCHASE ORDER (PO) 4501744107 ON 03.05.2017 INCLUDED 39 PIECES OF SIZE 4 (01.06010.104, LOT#: 2905496) BUT ONLY 38 HAVE BEEN DELIVERED, 1 DEVICE WAS SCRAPPED DUE TO A SCRATCHED SURFACE. BOTH PO WERE SENT SEPARATELY TO THE SUPPLIER MEDICOAT BUT AT MEDICOAT BOTH ORDERS WERE PACKED AND LABELED ON 08.06.2017. IN THE CASE AT HANDS AFFECTING THE INNER AND OUTER LABEL, IT IS MENTIONED THAT THE LABELS DO NOT CORRESPOND TO EACH OTHER. THE INNER AND OUTER LABELS ARE NOT CONGRUENT AND GIVE DIFFERENT INFORMATION ABOUT THE SIZES AND SHAPE ("STANDARD" VERSUS "LATERAL") OF THE CONTENT OF THE PACKAGE. AS BOTH BATCHES HAVE BEEN PACKAGED AND LABELLED AT SUPPLIER MEDICOAT AT THE SAME DAY (JUNE 08, 2017) IT IS ASSUMED THAT THERE WAS A LINE CLEARANCE ISSUE AT THE SUPPLIER MEDICOAT WHICH LEAD TO A LABEL MIX-UP AND A MISSING LABEL IN THE PACKAGING. LT WAS FOUND OUT THAT THE DOCTOR INTENDED TO IMPLANT PRODUCT 01.06010.003 (SIZE 3 AVENIR STEM, STANDARD) BUT DUE TO PACKAGING PRODUCT MIX-UP, THE SURGEON IMPLANTED PRODUCT 01.06010.004 (SIZE 4 AVENIR STEM, LATERAL), THEREFORE THE PRODUCT WAS NON-CONFORMING TO SPECIFICATION. A SCAR (SUPPLIER CORRECTIVE ACTION REQUEST) WAS INITIATED ON FEBRUARY 23RD, 2018 TO ADDRESS THE ISSUE AT SUPPLIER MEDICOAT. THE FIELD ACTION FA 2018-02 (ZFA2018-23) HAS BEEN INITIATED. ZIMMER GMBH IS CONDUCTING A VOLUNTARY MEDICAL DEVICE FIELD ACTION (REMOVAL OF ALL REMAINING IMPLANTS IN THE MARKETS) FOR THE TWO SPECIFIC LOT NUMBERS LOT#: 2905496 AND LOT#: 2904368. INVESTIGATION REVEALED THAT THERE IS A POTENTIAL PRODUCT MIX UP WITHIN THE PACKAGING BETWEEN AVENIR MULLER STEM SIZE 3, STANDARD AND AVENIR MULLER STEM SIZE 4, LATERAL. AS A PRECAUTIONARY MEASURE IT WAS DECIDED TO REMOVE ALL REMAINING IMPLANTS IN THE MARKETS. ALL AFFECTED HOSPITALS AND SURGEONS THAT HAVE RECEIVED THESE PRODUCTS HAVE BEEN NOTIFIED. NOTE: THE AFFECTED LOTS WERE NOT DISTRIBUTED IN USA. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IT WAS DETECTED AFTER A SURGERY THAT THE PATIENT LABELS WHICH CAN BE FOUND INSIDE THE AVENIR PACKAGING DID NOT CORRESPOND WITH THE LABEL ON THE OUTSIDE OF THE PACKAGING. THE PACKAGING WAS LABELLED WITH AN AVENIR STEM SIZE 3, STANDARD (REF: (B)(4) LOT: 2904368) AND THE LABELS INSIDE MARKED WITH AN AVENIR STEM SIZE 4, LATERAL (REF: (B)(4) LOT: 2905496). NO PATIENT HARM HAS BEEN REPORTED. DURING INVESTIGATION, IT COULD BE DETERMINED BASED ON POST-OPERATIVE X-RAYS THAT THE AVENIR STEM SIZE 4, LATERAL HAS BEEN IMPLANTED. PLANNED PRODUCT FOR SURGERY: SIZE 3 STANDARD. LABEL OUTSIDE: SIZE 3 STANDARD. PRODUCT INSIDE THE PACKAGING: SIZE 4 LATERAL. PRODUCT LABEL INSIDE THE BOX: SIZE 4 LATERAL. PRODUCT IMPLANTED: SIZE 4 LATERAL.

    Additional Manufacturer Narrative · 1

    X-RAYS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A SURGERY ON (B)(6) 2017 THE PATIENT LABELS WHICH CAN BE FOUND INSIDE THE AVENIR PACKAGING DID NOT CORRESPOND WITH THE LABEL ON THE OUTSIDE OF THE PACKAGING. THE ACTUAL INFORMATION RECEIVED DOES NOT CLEARLY MENTION IF THE PATIENT WAS IMPLANTED WITH THE DESIRED IMPLANT. IT WAS ALSO REPORTED THAT THE SURGERY WAS SUCCESSFULLY COMPLETED AND NO PATIENT HARM HAS BEEN REPORTED. IT IS UNCLEAR WHETHER: (AVENIR MUELLER, STEM, LATERAL, UNCEMENTED, HA, 4, TAPER 12/14 REF# (B)(4)) OR (AVENIR MUELLER, STEM, STANDARD, UNCEMENTED, HA, 3, TAPER 12/14 REF# (B)(4)) WAS IMPLANTED. - PATIENT LABEL RECEIVED REF# (B)(4), LOT# 2905496. - OUTSIDE PACKAGING REF# (B)(4), LOT# 2904368.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886365 AVENIR MÜLLER, STEM, STANDARD, UNCEMENTED, HA, 3, TAPER 12/14 AVENIR MULLER STEM LZO ZIMMER GMBH N/A 2904368

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other