BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLENOID BASEPLATE 10 DEG FW AUG

    MDR report key: 21952778 · Received May 2, 2025

    Report

    Report Number
    3002788818-2025-00044
    Event Type
    Malfunction
    Date Received
    May 2, 2025
    Date of Event
    April 11, 2025
    Report Date
    October 14, 2025
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    PHX
    PMA / PMN Number
    K220847
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED DEVICES WERE RETURNED AND EVALUATED. THE VISUAL INSPECTION REVEALED THE DEVICE RETURNED WITH THE THREADED SHAFT OF AN UNKNOWN INSERTION DEVICE FRACTURED IN THE THREADED CHANNEL. THE DEVICE IS LIGHTLY WORN FROM USE. FOR THE UNKNOWN INSERTION DEVICE, DEVICE SPECIFIC IDENTIFIERS WERE NOT PROVIDED. THEREFORE, AN EVALUATION OF THE MANUFACTURING RECORDS, COMPLAINT HISTORY REVIEW, INSTRUCTIONS FOR USE, RISK MANAGEMENT FILE AND PRIOR ACTIONS REVIEW COULD NOT BE PERFORMED. FOR THE OTHER DEVICE, A REVIEW OF THE PRODUCTION ORDER DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF COMPLAINT HISTORY FOR THE PART NUMBER OVER THE PAST 12 MONTHS AND FOR THE BATCH NUMBER BASED ON HISTORICAL DATA OF THE DEVICE DID NOT REVEAL SIMILAR EVENTS FOR THE LISTED DEVICE. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. A HISTORICAL REVIEW CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS PRODUCT AND EVENT. AT THIS TIME, WE HAVE NO EVIDENCE TO CONCLUDE THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. THIS DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES. DAMAGE FROM PROLONGED USE, MISUSE OR ROUGH HANDLING ARE LIKELY POTENTIAL FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT. WE RECOMMEND THAT ALL REUSABLE INSTRUMENTS BE ROUTINELY INSPECTED FOR WEAR AND DAMAGE AND REPLACED AS NECESSARY. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT 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 · 0

    H2: ADDITIONAL INFORMATION IN D9 (DEVICE RECEIVED) & D10 (CONCOMITANT DEVICE). CORRECTED INFORMATION IN D4 (CATALOG & UDI NUMBERS) AND H3.

    Additional Manufacturer Narrative · 0

    H11: INTERNAL COMPLAINT REFERENCE (B)(4). H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PRODUCT PROBLEM ASSOCIATED WITH A SMITH+NEPHEW DEVICE. THE REPORTED PROBLEM RELATES TO KNOWN INHERENT DEVICE AND/OR PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INVESTIGATIVE FINDINGS OR INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SHOULDER REPLACEMENT SURGERY, THE INSERTER BROKE INTO ONE (1) GLENOID BASEPLATE 10 DEG FW AUG DURING IMPLANTATION. THE PROCEDURE WAS RESUMED WITHOUT SURGICAL DELAY USING A SMITH+NEPHEW BACK-UP DEVICE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208305 GLENOID BASEPLATE 10 DEG FW AUG SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ASCENSION ORTHOPEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GBP-0990-502-10F.