BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LGN PRESSFIT STEM 14MM X 120MM

    MDR report key: 11188741 · Received January 18, 2021

    Report

    Report Number
    1020279-2021-00451
    Event Type
    Malfunction
    Date Received
    January 18, 2021
    Date of Event
    December 29, 2020
    Report Date
    November 24, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    03596010546678
    PMA / PMN Number
    K072531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION RECEIVED BY THE MANUFACTURER HAS BEEN RE-EVALUATED FOR MDR REPORTING AND IT WAS DETERMINED THAT THIS CASE DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT, BECAUSE OF THE FOLLOWING REASON: THE NONCONFORMITY WAS IDENTIFIED IN A SMITH AND NEPHEW WAREHOUSE IN THREE DEVICES (REPORT NUMBERS: 1020279-2021-00488, 1020279-2021-00487) AND ACTIONS HAVE BEEN TAKEN TO ADDRESS THE PROBLEM INTERNALLY WITHIN THE SMITH AND NEPHEW QUALITY SYSTEM. IF FURTHER DETAILS ARE PROVIDED CONFIRMING THE OCCURRENCE OF A REPORTABLE EVENT, OUR FILES WILL BE UPDATED ACCORDINGLY AND A FURTHER REPORT SUBMITTED OUTLINING BOTH THE EVENT DETAILS AND OUR INVESTIGATIONS PERFORMED. INTERNAL REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED DEVICE, INTENDED FOR USE IN TREATMENT, WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE STATED FAILURE MODE. THE DEVICE BOX LABEL IS CUT OFF AND MISSING THE CATALOG NUMBER AND QUANTITY. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES; THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS AND ASSESSED FOR ANY NECESSARY CORRECTIVE ACTIONS. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. AT THIS TIME, WE HAVE REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE POTENTIAL PROBABLE CAUSE FOR THIS EVENT IS LIKELY A MANUFACTURING PROCESS ERROR. THIS FAILURE MODE HAD BEEN PREVIOUSLY IDENTIFIED AND THE DEVICE WAS RE-DESIGNED TO PREVENT THE REOCCURRENCE OF THIS FAILURE MODE. THE RETURNED DEVICE WAS MANUFACTURED PRIOR TO THESE DESIGN CHANGES. THIS ISSUE IS BEING EVALUATED THROUGH OUR INTERNAL QUALITY HOLD PROCESS. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 0

    H3, H6: THE ASSOCIATED DEVICE, INTENDED FOR USE IN TREATMENT, WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE STATED FAILURE MODE. THE DEVICE BOX LABEL IS CUT OFF AND MISSING THE CATALOG NUMBER AND QUANTITY. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES; THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS AND ASSESSED FOR ANY NECESSARY CORRECTIVE ACTIONS. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. AT THIS TIME, WE HAVE REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE POTENTIAL PROBABLE CAUSE FOR THIS EVENT IS LIKELY A MANUFACTURING PROCESS ERROR. THIS ISSUE IS BEING EVALUATED THROUGH OUR INTERNAL QUALITY HOLD PROCESS. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LABEL ON THE PACKAGING IS NOT COMPLIANCE. IT DOES NOT CONTAIN THE SKU NUMBER. NO CASE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85673 LGN PRESSFIT STEM 14MM X 120MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CNSTRND, CEMENTED, POLY/METAL/POLY JWH SMITH & NEPHEW, INC. 71424027 20DSM0127 03596010546678

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown