BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOS REVERSE BODY Ø36/10MM NON-CEMENTED

    MDR report key: 8194095 · Received December 24, 2018

    Report

    Report Number
    9613369-2018-00091
    Event Type
    Injury
    Date Received
    December 24, 2018
    Date of Event
    November 28, 2018
    Report Date
    May 1, 2019
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    KWS
    PMA / PMN Number
    K081016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: A REVISION SURGERY OF A PROMOS SHOULDER AFTER A BICYCLE ACCIDENT WAS REPORTED. NO RELEVANT SUPPORTING CLINICAL INFORMATION HAS BEEN PROVIDED TO ASSIST WITH A CLINICAL INVESTIGATION, AND THE PATIENT'S CURRENT CONDITION IS UNKNOWN. THEREFORE BASED ON INSUFFICIENT INFORMATION, A THOROUGH CLINICAL ASSESSMENT COULD NOT BE PERFORMED. A REVIEW OF THE BATCH RECORD REVEALED NO DEVIATIONS FROM THE STANDARD MANUFACTURING PROCESS THAT WOULD INDICATE THAT THE REPORTED DEVICES FAILED TO MATCH SPECIFICATIONS AT THE TIME OF MANUFACTURING. A REVIEW OF THE COMPLAINT HISTORY REVEALED NO OTHER COMPLAINTS FOR THE BATCHES IN QUESTION. SINCE THE DEVICES IN QUESTION WERE NOT SENT BACK FOR INVESTIGATION, AN APPROPRIATE PRODUCT EVALUATION COULD NOT BE PERFORMED. BASED ON AVAILABLE INFORMATION THE STATED FAILURE MODE CANNOT BE CONFIRMED. THE EXECUTED INVESTIGATION STEPS GIVE NO INDICATION FOR THE NEED OF CORRECTIVE ACTION. NEVERTHELESS, SMITH AND NEPHEW WILL CONTINUE TO MONITOR THIS DEVICE FOR SIMILAR ISSUES. THE COMPLAINT WILL BE REOPENED SHOULD ADDITIONAL INFORMATION OR THE DEVICES IN SCOPE BE RECEIVED.

    Description of Event or Problem · 0

    A REVISION SURGERY OF THE PROMOS SHOULDER WAS REPORTED AFTER A BICYCLE ACCIDENT. EXTRACTION INSTRUMENTS WERE INITIALLY UNAVAILABLE BUT BACK-UPS WERE AVAILABLE AND REVISION WAS COMPLETED. THE SHOULDER BODY REVERSE DEVICE AND MATING PARTS WERE EXPLANTED AS CONSEQUENCE OF THE FALL. STEM REMAINED IMPLANTED.

    Description of Event or Problem · 1

    A REVISION SURGERY OF THE PROMOS SHOULDER WAS REPORTED AFTER A BICYCLE ACCIDENT. SURGERY WAS CANCELED DUE TO AN INSTRUMENT UNAVAILABILITY. THE SHOULDER IMPLANT REQUIRING REVISION IS UNKNOWN AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033162 PROMOS REVERSE BODY Ø36/10MM NON-CEMENTED PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS SMITH & NEPHEW ORTHOPAEDICS AG

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention 75003698,PROMOS REV GLEN.BONE SCREW,A1016499| 75003699,PROMOS REV GLEN.BONE SCREW,A1016884| 75003704,PROMOS REVERSE PE INSERT,A0808728| 75003708,PROMOS REVERSE GLENOSPHERE,B1017718| 75003722,PROMOS REVERSE GLENBASE PLATE,B1022028