BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENGAGE POROUS FEMORAL SZ 2-RT MED

    MDR report key: 19919034 · Received August 6, 2024

    Report

    Report Number
    1020279-2024-01490
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    March 23, 2023
    Report Date
    September 2, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NJD
    UDI-DI
    00885556872949
    PMA / PMN Number
    K190439
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6 (TYPE OF INVESTIGATION AND INVESTIGATION FINDINGS), H10 ((B)(4)). H3, H6: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. DEVICE BATCH NUMBER WAS NOT PROVIDED; THUS, AN EVALUATION OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. A REVIEW OF COMPLAINT HISTORY BASED ON THE HISTORICAL DATA REVEALED SIMILAR PREVIOUS EVENTS, HOWEVER NO COMMONALITIES THAT WOULD SUGGEST A DEVICE DEFICIENCY WERE FOUND. A REVIEW OF THE INSTRUCTIONS FOR USE DOCUMENTS FOR ENGAGE PARTIAL KNEE SYSTEM REVEALED THAT FRACTURE HAS BEEN IDENTIFIED IN ADVERSE EFFECTS AND COMPLICATIONS. THERE IS NOT ENOUGH DATA AVAILABLE TO CONCLUDE THAT THE OVERALL CLINICAL BENEFIT OUTWEIGHS THE POTENTIAL RISK PROFILE WHEN COMPARED TO THE STATE OF THE ART. THE EXISTING DATA IDENTIFIES A POTENTIAL SIGNAL THAT THE PERFORMANCE IS AN OUTLIER VS THE STATE OF THE ART WITH RESPECT TO THE RISK FOR REVISION. IN ADDITION, A HISTORICAL REVIEW CONCLUDED THAT NO PREVIOUS ESCALATED ACTIONS FOR THIS TYPE OF ISSUE WERE IDENTIFIED. HOWEVER, AS A CORRECTION ACTION A VOLUNTARY MARKET REMOVAL WILL BE PERFORMED FOR THE ENGAGE CEMENTLESS PARTIAL KNEE SYSTEM DUE RECENT COMPLAINT DATA THAT INDICATES THAT THE REVISION RATE MAY BE TRENDING HIGHER THAN CORRESPONDING SIMILAR DEVICES IN GLOBAL JOINT REPLACEMENT REGISTRIES. AT THIS TIME, WE HAVE NO EVIDENCE TO CONCLUDE THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT INCLUDE TRAUMATIC INJURY, JOINT TIGHTNESS, PATIENT CONDITION OR POSTOPERATIVE CARE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION MAY BE 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 Manufacturer Narrative · 0

    INTERNAL REFERENCE NUMBER: (B)(4). ADDITIONAL INFORMATION: H6, H7, H10. H10: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION IDENTIFIED THROUGH THE REVIEW OF CLINICAL EVIDENCE FROM POST MARKET CLINICAL DATA COLLECTION ACTIVITIES THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT. THE REPORTED ISSUE(S) RELATE 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. IT SHOULD BE NOTED THAT THIS PRODUCT WAS RECALLED FROM THE MARKET ON 02-MAY-2023 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 CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL 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, AFTER A RIGHT UNICOMPARTMENTAL KNEE ARTHROPLASTY, THE PATIENT EXPERIENCED AN USPECIFIED FRACTURE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2023. CURRENT HEALTH STATUS OF PATIENT IN UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1560083 ENGAGE POROUS FEMORAL SZ 2-RT MED PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, NJD SMITH & NEPHEW, INC. UNKNOWN 00885556872949

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention 1-10012-450/ENGAGE POROUS TIBIAL TRAY SZ 4-RT MED.| 1-10013-159/ENGAGE TIBIAL INSERT SZ 1-RT MED 9MM.