BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN CEMENTLESS PARTIAL KNEE IMPL

    MDR report key: 14227811 · Received April 27, 2022

    Report

    Report Number
    1020279-2022-02004
    Event Type
    Injury
    Date Received
    April 27, 2022
    Date of Event
    November 1, 2021
    Report Date
    June 27, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NJD
    PMA / PMN Number
    K190439
    Removal / Correction Number
    RES 92286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, THE BILATERAL X-RAYS IMAGES DATED (B)(6) 2022, WERE REVIEWED BUT CANNOT CONFIRM THE REPORTED ANCHOR INSIDE OF THE PATIENT¿S LEFT LEG. THE IMAGES CANNOT CONFIRM THE CLINICAL ROOT CAUSE OF THE REPORTED BREAKAGE. ANCHORS ARE IMPLANTABLE SO BIOCOMPATIBLE IS NOT AN ISSUE. THE IMPLANTABLE ANCHOR IS REPORTEDLY SECURE INSIDE OF THE PATIENT¿S BONE. THEREFORE, MICROMOTION/MIGRATION OF THE RETAINED BROKEN ANCHOR IS UNLIKELY. REPORTEDLY, THE PATIENT¿S LEFT LEG IS ASYMPTOMATIC AND NOT CAUSING ANY PROBLEMS. SINCE NO ADDITIONAL SURGERY HAS BEEN SCHEDULED YET TO TREAT THIS ADVERSE EVENT, NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. POSSIBLE CAUSES COULD INCLUDE BUT NOT LIMITED TO TRAUMATIC INJURY, PATIENT ANATOMY OR ABNORMAL LOADING OF LIMB. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE CORROBORATED. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. WITHOUT THE RETURN OF THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION COULD NOT PROCEED. 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

    H3, H6, H7, H9: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, THE BILATERAL X-RAYS IMAGES DATED (B)(6) 2022, WERE REVIEWED BUT CANNOT CONFIRM THE REPORTED ANCHOR INSIDE OF THE PATIENT¿S LEFT LEG. THE IMAGES CANNOT CONFIRM THE CLINICAL ROOT CAUSE OF THE REPORTED BREAKAGE. ANCHORS ARE IMPLANTABLE SO BIOCOMPATIBLE IS NOT AN ISSUE. THE IMPLANTABLE ANCHOR IS REPORTEDLY SECURE INSIDE OF THE PATIENT¿S BONE. THEREFORE, MICROMOTION/MIGRATION OF THE RETAINED BROKEN ANCHOR IS UNLIKELY. REPORTEDLY, THE PATIENT¿S LEFT LEG IS ASYMPTOMATIC AND NOT CAUSING ANY PROBLEMS. SINCE NO ADDITIONAL SURGERY HAS BEEN SCHEDULED YET TO TREAT THIS ADVERSE EVENT, NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. DEVICE SPECIFIC IDENTIFIERS WERE NOT PROVIDED. THEREFORE, AN EVALUATION OF THE MANUFACTURING RECORDS AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. 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 REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT INCLUDE SIZE SELECTED, SURGICAL TECHNIQUE, PATIENT ANATOMY, ABNORMAL LOADING OF LIMB, EXCESSIVE FORCES AND/OR TRAUMATIC INJURY. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION MAY BE INDICATED.

    Description of Event or Problem · 0

    BILATERAL PATIENT. IT WAS REPORTED THAT, AFTER A LEFT UNICOMPARTMENTAL KNEE ARTHROPLASTY HAD BEEN PERFORMED AROUND (B)(6) 2021, THE PATIENT EXPERIENCED THE BREAKAGE OF THE ANCHOR KNEE COMPONENT AS CONFIRMED BY X-RAY IMAGES. THE LEFT LEG IS ASYMPTOMATIC AND NOT CAUSING ANY PROBLEMS TO THE PATIENT. NO ADDITIONAL SURGERY HAS BEEN SCHEDULED YET TO TREAT THIS ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1591446 UNKN CEMENTLESS PARTIAL KNEE IMPL PROSTH, KNEE, FEMO, SEMI-CONS, UNICOM/UNICON, UNCEM, POROUS-COATED, METAL/POLY NJD SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention