BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORATION(TM) ADM. PRESS

    MDR report key: 6999462 · Received November 3, 2017

    Report

    Report Number
    0002249697-2017-03198
    Event Type
    Malfunction
    Date Received
    November 3, 2017
    Date of Event
    October 6, 2017
    Report Date
    January 15, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K161569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A MISSING COMPONENT INVOLVING AN ADM PRESS WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: A VISUAL INSPECTION OF THE RESTORATION ADM PRESS SHOWED THAT THE SMALL PIN IS MISSING ON THE INSTRUMENT. MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW BY A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW: DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES COMPLAINT HISTORY REVIEW: A REVIEW OF THE COMPLAINT HISTORY DATABASE SHOWS THAT THERE HAS BEEN ONE OTHER EVENT FOR THE LOT REFERENCED. CONCLUSIONS: THE SUBJECT DEVICE WAS DETERMINED TO HAVE BEEN MANUFACTURED BEFORE THE IMPLEMENTATION OF CAPA. THE CAPA CONCLUDED THAT THE ROOT CAUSE OF THE OCCURRENCE WAS DUE TO THE REAMER TO MANUFACTURE THE PIN HOLE WAS OUT OF SPECIFICATION. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RESTORATION ADM PRESS IS MISSING A SMALL PIN OR SCREW THAT HOLDS IT TOGETHER. A STRYKER SALES REP FOUND THE GREEN PLASTIC END FELL OF THE INSTRUMENT. THE SURGEON HAD TO IMPROVISE A WAY OF CLAMPING THE HEAD AND MDM POLY INSERT TOGETHER USING THE REST OF THE CLAMP AND VARIOUS OTHER PIECES OF GENERIC KIT. THIS WAS EVENTUALLY ACHIEVED. THERE WAS A SURGICAL DELAY OF APPROXIMATELY 10 MINUTES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RESTORATION ADM PRESS IS MISSING A SMALL PIN OR SCREW THAT HOLDS IT TOGETHER. A STRYKER SALES REP FOUND THE GREEN PLASTIC END FELL OF THE INSTRUMENT. THE SURGEON HAD TO IMPROVISE A WAY OF CLAMPING THE HEAD AND MDM POLY INSERT TOGETHER USING THE REST OF THE CLAMP AND VARIOUS OTHER PIECES OF GENERIC KIT. THIS WAS EVENTUALLY ACHIEVED. THERE WAS A SURGICAL DELAY OF APPROXIMATELY 10 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780325 RESTORATION(TM) ADM. PRESS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH G3257913

    Patients

    Seq Age Sex Outcome Treatment
    1 Other