BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAP SPACER

    MDR report key: 23288596 · Received October 15, 2025

    Report

    Report Number
    1020279-2025-01697
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 16, 2025
    Report Date
    November 13, 2025
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWT
    UDI-DI
    00885556578445
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE PHOTOGRAPHS WERE REVIEWED, AND REVEALED THAT THE SPACER IS FRACTURED. 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 BASED ON THE HISTORICAL DATA REVEALED SIMILAR EVENTS FOR THE LISTED BATCH, THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS FOR ANY NECESSARY CORRECTIVE ACTIONS. A REVIEW OF THE INSTRUCTIONS FOR USE DOCUMENTS FOR CARE, MAINTENANCE, CLEANING AND STERILIZATION OF SMITH & NEPHEW ORTHOPEDICS DEVICES REVEALED THAT VISUALLY INSPECTING FOR DAMAGE OR WEAR, INCLUDING COMPONENTS IN THEIR DISASSEMBLED STATE PRIOR TO RE-ASSEMBLY AS WELL AS ENSURING COMPONENTS ARE RE-ASSEMBLED SECURELY IS INDICATED. 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 THE DEVICE OR 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 INFORMATION: D4 (LOT NUMBER, EXPIRATION DATE), E1, H4, H8. CORRECTED DATA: B1, B2, B5, D6A / D6B (NOT APPLICABLE FOR THIS DEVICE).

    Additional Manufacturer Narrative · 0

    D10 HAS BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    INTERNAL REFERENCE NUMBER: (B)(4). H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION REPORTED THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT WITHOUT EVIDENCE ABOUT A SPECIFIC PRODUCT PROBLEM. THE REPORTED COMPLICATION RELATES TO KNOWN INHERENT 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 CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR 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 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 UKA SURGERY PERFORMED ON (B)(6) 2025, THE GAP SPACER BROKE DURING CEMENTING AND CAUSED A SIGNIFICANT DELAY IN THE CASE. THE PIECE THAT BROKE WAS INACCESSIBLE WITH IMPLANTS IN AS IT HAD FALLEN INTO THE POSTERIOR MEDIAL COMPARTMENT BEHIND THE TIBIA. THIS ADVERSE EVENT WAS TREATED BY REMOVING THE CEMENTED IMPLANTS AND CONVERT TO A TOTAL KNEE TO RETRIEVE TO BROKEN PIECE. PATIENT'S CURRENT HEALTH STATUS IS FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A TKA SURGERY PERFORMED ON (B)(6) 2025, THE GAP SPACER BROKE DURING CEMENTING AND CAUSED A SIGNIFICANT DELAY IN THE CASE. THE PIECE THAT BROKE WAS INACCESSIBLE WITH IMPLANTS IN AS IT HAD FALLEN INTO THE POSTERIOR MEDIAL COMPARTMENT BEHIND THE TIBIA. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON THE SAME DAY TO REMOVE THE CEMENTED IMPLANTS AND CONVERT TO A TOTAL KNEE TO RETRIEVE TO BROKEN PIECE. THE BROKEN PIECE WAS RETRIEVED. PATIENT'S CURRENT HEALTH STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2646926 GAP SPACER TEMPLATE HWT SMITH & NEPHEW, INC. 19LDN7779 00885556578445

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O 71935180 / LOT NUMBER: 19LDN7779.| 74026724 / LOT NUMBER: 24FAP0040A.