BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GENESIS II REVISION KNEE IMPL

    MDR report key: 16876548 · Received May 5, 2023

    Report

    Report Number
    1020279-2023-00987
    Event Type
    Injury
    Date Received
    May 5, 2023
    Date of Event
    July 7, 2021
    Report Date
    June 2, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). HINES, JEREMY T. MD1; LEWALLEN, DAVID G. MD1; PERRY, KEVIN I. MD1; TAUNTON, MICHAEL J. MD1; PAGNANO, MARK W. MD1; ABDEL, MATTHEW P. MD1,A. BICONVEX PATELLAR COMPONENTS: 96% DURABILITY AT 10 YEARS IN 262 REVISION TOTAL KNEE ARTHROPLASTIES. THE JOURNAL OF BONE AND JOINT SURGERY 103(13):P 1220-1228, JULY 7, 2021. / DOI: 10.2106/JBJS.20.01064. THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION IDENTIFIED THROUGH A REVIEW OF CLINICAL EVIDENCE FROM LITERATURE SOURCES 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 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 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.

    Additional Manufacturer Narrative · 0

    THE DEVICES WERE NOT RETURNED FOR EVALUATION; THEREFORE, DEVICES ANALYSIS COULD NOT BE PERFORMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, PER THE COMPLAINT DETAILS, 2 PATIENTS (SITED FROM A RETROSPECTIVE COHORT STUDY/LITERATURE REVIEW) EXPERIENCED PERONEAL NERVE PALSY WITH SUBSEQUENT IMPROVEMENT. IT IS UNKNOWN IF INTERVENTIONS WERE REQUIRED OR HOW THESE COMPLICATIONS WERE TREATED. AS OF THE DATE OF THIS MEDICAL INVESTIGATION, CLINICAL DOCUMENTATION HAS NOT BEEN RECEIVED AND THE CURRENT STATUS OF THE PATIENTS ARE UNKNOWN. THE IMAGES PROVIDED IN THE ARTICLE HAVE BEEN INTERPRETED WITHIN THE TEXT BY ONE NON-INDEPENDENT AUTHOR AND DO NOT PROVIDE INSIGHT INTO THIS REPORTED EVENT; THEREFORE, NO FURTHER ANALYSIS OF THE IMAGING IS REQUIRED. WITHOUT PATIENT SPECIFIC MEDICAL DOCUMENTATION, DEFINITIVE CONTRIBUTING FACTORS TO THE REPORTED PERONEAL NERVE PALSY COULD NOT BE CONCLUDED; HOWEVER, THIS IS A KNOWN POTENTIAL PROCEDURAL COMPLICATION AND A COMPONENT MALPERFORMANCE WAS NOT SUPPORTED. THE IMPACT TO THE PATIENTS BEYOND THOSE WHICH WERE REPORTED CANNOT NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED IN THE LITERATURE, ALTHOUGH ¿SUBSEQUENT IMPROVEMENT¿ WAS REPORTED. NO FURTHER MEDICAL ASSESSMENT CAN BE RENDERED AT THIS TIME. DEVICES SPECIFIC IDENTIFIERS WERE NOT PROVIDED. THEREFORE, AN EVALUATION OF THE MANUFACTURING RECORDS, COMPLAINT HISTORY REVIEW, INSTRUCTIONS FOR USE, RISK MANAGEMENT FILE AND PRIOR ACTIONS REVIEW COULD NOT BE PERFORMED. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCTS FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT INCLUDE PROCEDURAL/USER ERROR, TRAUMATIC INJURY OR PATIENT MEDICAL HISTORY. 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. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW "BICONVEX PATELLAR COMPONENTS 96% DURABILITY AT 10 YEARS IN 262 REVISION TOTAL KNEE ARTHROPLASTIES", AFTER A TKA REVISION SURGERY USING A GENESIS INSET BICONVEX PATELLAR COMPONENT, 2 PATIENTS EXPERIENCED PERONEAL NERVE PALSY WITH SUBSEQUENT IMPROVEMENT. IT IS UNKNOWN HOW THESE COMPLICATIONS WERE TREATED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2195796 UNKNOWN GENESIS II REVISION KNEE IMPL PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention