BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALPHA INSERT, PE, HOODED, LL/32

    MDR report key: 8234936 · Received January 10, 2019

    Report

    Report Number
    0009613350-2019-00009
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    December 10, 2018
    Report Date
    June 27, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    LPH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THE DHR REVIEW SHOWS THAT THE OUTER DIAMETER WAS MEASURED WITH A CALIPER IN EVERY DEVICE OF LOT# 2972157. THE OUTER DIAMETER WAS FOUND TO BE WITHIN SPECIFICATION IN ALL 50 OUT OF 50 PARTS. NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: DID NOT FIT (ASSEMBLY ISSUE) EVENT SUMMARY: IT WAS REPORTED THAT DURING A PRIMARY TOTAL HIP REPLACEMENT IT WAS NOT POSSIBLE TO INSERT THE ALPHA INLAY 32/LL HOODED. AFTER FOUR ATTEMPTS THE SURGEON USED A NEW INLAY WITHOUT ANY PROBLEMS. REVIEW OF RECEIVED DATA NO MEDICAL DATA SUCH AS SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS - VISUAL EXAMINATION: THE ALPHA PE INSERT HOODED SHOWS A FLATTENED CENTER PIN. FURTHER, THE INLAY IS SLIGHTLY OVAL. OTHERWISE, NOTHING CONSPICUOUS TO REPORT. BASED ON THIS VISUAL EXAMINATION THE REPORTED EVENT CAN BE CONFIRMED. - MEASUREMENTS: ACCORDING TO THE PER THE DEVICE WAS PUT INTO THE WASHING MACHINE FOR CLEANING BEFORE SENDING THE DEVICE TO US FOR INVESTIGATION. IT MAY BE THAT THIS CLEANING TREATMENT ALTERED THE DIMENSIONS OF THE INLAY, AS POLYETHYLENE IS SENSITIVE TO HEAT TREATMENT. THEREFORE, NO DIMENSIONAL MEASUREMENTS WERE PERFORMED. REVIEW OF PRODUCT DOCUMENTATION THIS DEVICE IS INTENDED FOR TREATMENT. - COMPATIBILITY: COMPATIBILITY CHECK COULD NOT BE PERFORMED AS ONLY ONE PRODUCT HAD BEEN REPORTED. ROOT CAUSE ANALYSIS ROOT CAUSE DETERMINATION USING RMW: - DEFORMATION OF INSERT (DUE TO LOAD) DUE TO OVALISATION OF COMPATIBLE SHELL COMPONENT => POSSIBLE, AS THIS CANNOT BE EXCLUDED BASED ON THE PROVIDED INFORMATION. - INTRAOPERATIVE COMPLICATIONS DUE TO INCORRECT ASSOCIATED INSTRUMENTS USED => POSSIBLE, AS THIS CANNOT BE EXCLUDED BASED ON THE PROVIDED INFORMATION. - INTRAOPERATIVE COMPLICATIONS DUE TO WRONG POSITIONED INSERT IN SHELL => POSSIBLE, AS THIS CANNOT BE EXCLUDED BASED ON THE PROVIDED INFORMATION. CONCLUSION SUMMARY IT WAS REPORTED THAT DURING A PRIMARY TOTAL HIP REPLACEMENT IT WAS NOT POSSIBLE TO INSERT THE ALPHA INLAY. AFTER FOUR ATTEMPTS THE SURGEON USED A NEW INLAY WITHOUT ANY PROBLEMS. THE VISUAL EXAMINATION SHOWED THAT THE INLAY IS SLIGHTLY OVAL AND HAS A FLATTENED PIN, WHICH INDICATES MISALIGNMENT OF THE INLAY WITHIN THE SHELL PRIOR OR DURING IMPACTION. ACCORDING TO THE PER THE DEVICE WAS PUT INTO THE WASHING MACHINE FOR CLEANING BEFORE SENDING THE DEVICE TO US, ZIMMER BIOMET. IT MAY BE POSSIBLE THAT THIS CLEANING TREATMENT ALTERED THE DIMENSIONS OF THE INLAY, AS POLYETHYLENE IS SENSITIVE TO HEAT TREATMENT. THEREFORE, DIMENSIONAL MEASUREMENTS COULD NOT BE PERFORMED. THE SHELL USED TOGETHER WITH THE INLAY IS UNKNOWN, THEREFORE, THE COMPATIBILITY OF THE PRODUCT COMBINATION COULD NOT BE REVIEWED, USAGE OF A WRONG PRODUCT COMBINATION CANNOT BE EXCLUDED. THE SURGICAL TECHNIQUE STATES THAT THE MATING SURFACES MUST BE PERFECTLY CLEAN AND FREE FROM ANY TISSUE RESIDUES PRIOR TO INLAY INSERTION. FURTHER, THE LINER MUST BE PERFECTLY ALIGNED WITHIN THE SHELL, IN ORDER TO AVOID MISPOSITIONING. ALIGNMENT BETWEEN THE INLAY AND THE SHELL IS PROVIDED BY INSERTING THE PEG OF THE LINER INSIDE THE POLE PLUG OF THE SHELL. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION THE MOST LIKELY CAUSES FOR THE REPORTED ISSUE ARE MISALIGNMENT OF THE INLAY WITHIN THE SHELL PRIOR OR DURING IMPACTION, UNCLEAN MATING SURFACES OR A WRONG PRODUCT COMBINATION. IT MAY ALSO BE POSSIBLE THAT INAPPROPRIATE REAMING LED TO OVALISATION OF THE SHELL AND CONSEQUENTLY TO ISSUE DURING INLAY INSERTION. HOWEVER, BASED ON THE AVAILABLE INFORMATION, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE YET THE DEVICE, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. 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

    INLAY USED BY THE SURGEON WAS NOT FITTING. SURGEON USED ANOTHER TO COMPLETE THE SURGERY. SURGICAL DELAY WAS 10 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25452 ALPHA INSERT, PE, HOODED, LL/32 ALPHA INSERT LPH ZIMMER GMBH N/A 2972157

    Patients

    Seq Age Sex Outcome Treatment
    1 Other