BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGION PS OXIN FEM SZ5 LT

    MDR report key: 7241690 · Received February 5, 2018

    Report

    Report Number
    1020279-2018-00119
    Event Type
    Injury
    Date Received
    February 5, 2018
    Date of Event
    December 27, 2017
    Report Date
    May 23, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    PMA / PMN Number
    K043440
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SECOND REVISION SURGERY OF THE LEFT KNEE ON (B)(6) 2017 DUE TO PAIN AND LOOSENING OF HER FEMORAL AND TIBIAL COMPONENTS. DURING THE REVISION SURGERY A MASSIVE AMOUNT OF FLUID WAS FOUND. THE FEMORAL COMPONENT WAS GROSSLY LOOSE, AND THE TIBIAL COMPONENT WAS FOUND TO BE WELL FIXED, BUT EASY TO REMOVE. A COMPLETE SYNOVECTOMY WAS PERFORMED. ALL THE COMPONENTS WERE EXPLANTED DURING THE PROCEDURE. THE PRIMARY LEFT KNEE SURGERY WAS PERFORMED ON (B)(6) 2010 AND THE FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: CONCOMITANT DEVICE 510KS: K071071, K041106.

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED COMPLAINT DEVICES WERE RETURNED AND EVALUATED. FROM A LAB ANALYSIS CONDUCTED DURING THIS INVESTIGATION, IT IS CONCLUDED THAT THE FEMORAL COMPONENT SHOWED WEAR AND DAMAGE ON ARTICULAR SURFACE, CEMENT ADHESION ON BONE/IMPLANT SURFACE INTERFACE, AND GAP BETWEEN L WEDGE AND FEMORAL COMPONENT. TIBIAL INSERT SHOWED WEAR ON ARTICULAR SURFACE AND DAMAGE ON INFERIOR SURFACE. THE TIBIAL BASEPLATE SHOWED DAMAGE ON THE ANTERIOR SURFACE AND POLISHED SURFACE. A CLINICAL ANALYSIS CONCLUDED THE REPORTED INDICATION OF TRAUMA, RADIOLOGICAL FINDINGS (LUCENCIES, PATELLAR SUBLUXATION AND BUTTON DISASSOCIATION) APPROXIMATELY 1 YEAR PRIOR TO THE 1ST REVISION ALONG WITH DELAYED SURGICAL INTERVENTION ARE ALL LIKELY CONTRIBUTING FACTORS TO THE REPORTED 1ST REVISION. THERE WAS NO SUPPORTING DOCUMENTATION WAS PROVIDED REGARDING THE 2ND REVISION; HOWEVER, THE NOTED GAP BETWEEN THE L WEDGE AND THE FEMORAL COMPONENT ALONG WITH THE PATCHY CEMENT/BONE ADHESION ON BOTH THE TIBIAL AND FEMORAL COMPONENTS COULD HAVE BEEN CONTRIBUTING FACTORS. THE PATIENT IMPACT BEYOND THE REVISION SURGERIES CANNOT BE DETERMINED. NO FURTHER MEDICAL ASSESSMENT CAN BE RENDERED AT THIS TIME. A REVIEW OF COMPLAINT HISTORY ON THE LISTED PARTS REVEALED NO ADDITIONAL COMPLAINTS FOR THIS FAILURE MODE WITH THE SAME BATCH NUMBER. A REVIEW OF THE MANUFACTURING RECORDS FOR THE LISTED BATCHES DID NOT REVEAL ANY DEVIATION FROM THE STANDARD MANUFACTURING PROCESSES. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE FURTHER AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A REVISION LEFT TKR FOR UNSPECIFIED REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85336 LEGION PS OXIN FEM SZ5 LT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH SMITH & NEPHEW, INC. 13JM06414

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Hospitalization| R 71420166/10CT40953.| INSERT PART 71453249 LOT 14DM07573.| WEDGE PART 71421664 LOT 11KSM0500C.| WEDGE PART 71421741 LOT 12ESM0040A.