BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LGN XLPE DISHED ISRT SZ 3-4 15MM

    MDR report key: 22184554 · Received June 11, 2025

    Report

    Report Number
    1020279-2025-01045
    Event Type
    Injury
    Date Received
    June 11, 2025
    Date of Event
    May 21, 2025
    Report Date
    July 15, 2025
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    00885556255674
    PMA / PMN Number
    K071071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6 (HEALTH EFFECT - CLINICAL CODE, HEALTH EFFECT - IMPACT CODE [F1907 REMOVED] AND TYPE OF INVESTIGATION), H8 AND H11. H11: THE DEVICES WERE NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, BASED ON THE SURGEON¿S STATEMENT, ¿THE POSTERIOR CAPSULE APPEARED TO BE INTACT, AND THE DISLOCATION WAS ATTRIBUTED TO A LEVERING ACTION DURING SIMULTANEOUS KNEE FLEXION AND INTERNAL ROTATION.¿ ALTHOUGH A PROCEDURAL VARIANCE COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR¿ESPECIALLY CONSIDERING THE REPORTED SOFT TISSUE COMPLICATIONS DURING THE PRIMARY SURGERY¿OTHER ELEMENTS MAY HAVE ALSO PLAYED A ROLE. THESE INCLUDE THE USE OF A THICKER-THAN-USUAL 15MM POLYETHYLENE INSERT FOR STABILITY DESPITE ¿NORMAL CUTS,¿ EXCESSIVE CEMENT APPLICATION, AND THE REMOVAL OF A WELL-CEMENTED FEMORAL COMPONENT, WHICH RESULTED IN SIGNIFICANT BONE LOSS. ACCORDING TO THE REPORT, THE PATIENT IS CURRENTLY RECOVERING WELL. A REVIEW OF THE PRODUCTION ORDER FOR BOTH THE INSERT AND THE FEMORAL COMPONENT DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF COMPLAINT HISTORY FOR THE PART NUMBERS OVER THE PAST 12 MONTHS AND FOR THE BATCHES NUMBER BASED ON HISTORICAL DATA OF THE DEVICE DID NOT REVEAL SIMILAR EVENTS FOR THE LISTED DEVICES. A REVIEW OF THE INSTRUCTIONS FOR USE DOCUMENTS FOR LEGION¿ TOTAL KNEE SYSTEM REVEALED THAT DISLOCATION HAS BEEN IDENTIFIED IN ADVERSE EVENTS AS RESULT FROM TRAUMA, IMPROPER IMPLANT SELECTION, IMPROPER IMPLANT POSITIONING, IMPROPER FIXATION, AND/OR MIGRATION OF THE COMPONENTS. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS. A REVIEW OF THE RISK MANAGEMENT FILES 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 PRODUCTS AND EVENT. AT THIS TIME, WE HAVE NO EVIDENCE TO CONCLUDE THAT THE PRODUCTS FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT INCLUDE INJURY, PATIENT CONDITION, POSTOPERATIVE CARE, SIZE SELECTED OR ABNORMAL LOADING OF LIMB. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD THE DEVICES 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. INTERNAL COMPLAINT REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A TKA PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED A TIBIAL DISLOCATION WHILE ATTEMPTING TO MOVE HERSELF DOWN THE BED. DR. (B)(6) NOTED THAT THE POSTERIOR CAPSULE APPEARED TO REMAIN INTACT AND ATTRIBUTED THE DISLOCATION TO A LEVERING ACTION DURING SIMULTANEOUS KNEE FLEXION AND INTERNAL ROTATION. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2025. DURING THIS PROCEDURE, ONE (1) LEGION¿ CR OXIN FEM SZ3 LT AND ONE (1) LGN XLPE DISHED INSERT SZ 3-4 15MM WERE REMOVED. IT WAS DETERMINED THAT A POSTERIOR-STABILISED KNEE IMPLANT WOULD BE MORE APPROPRIATE TO PREVENT RECURRENCE. WHILE REMOVING THE WELL-CEMENTED FEMORAL COMPONENT, A SIGNIFICANT AMOUNT OF BONE REMAINED ATTACHED TO THE IMPLANT. AS A RESULT, A REVISION FEMORAL PROSTHESIS WITH A STEM AND AUGMENTS WAS USED TO COMPENSATE FOR THE BONE LOSS. THE POST ON THE POSTERIOR-STABILISED POLYETHYLENE INSERT SUCCESSFULLY PREVENTED FURTHER DISLOCATION, ALLOWING THE TIBIAL COMPONENT TO BE LEFT IN SITU. PATIENT IS RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96402 LGN XLPE DISHED ISRT SZ 3-4 15MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH SMITH & NEPHEW, INC. 24DM16893 00885556255674

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other PN: 71421233 / LOT: 24CM10697