BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE CONSTRUCT SIGMA

    MDR report key: 20759005 · Received November 22, 2024

    Report

    Report Number
    1818910-2024-24374
    Event Type
    Injury
    Date Received
    November 22, 2024
    Date of Event
    September 13, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY ORTHOPAEDICS IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY ORTHOPAEDICS HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY ORTHOPAEDICS OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY ORTHOPAEDICS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY- NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT/LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT- THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: HIPPALGAONKAR K, RAJEEV REDDY K, MULPUR P, JAYAKUMAR T, JOSHI S, REDDY AVG. MID-TERM SURVIVORSHIP AND FUNCTIONAL OUTCOMES OF METAPHYSEAL SLEEVES FOR ADDRESSING ANDERSON ORTHOPAEDIC RESEARCH INSTITUTE (AORI) TYPE 2 AND 3 BONE DEFECTS IN REVISION TOTAL KNEE ARTHROPLASTY. CUREUS. 2024 SEP 13;16(9):E69381. DOI: 10.7759/CUREUS.69381. PMID: 39403644; PMCID: PMC11472008. OBJECTIVE/METHODS/STUDY DATA: THIS RETROSPECTIVE OBSERVATIONAL STUDY INVESTIGATES THE CLINICAL OUTCOMES AND COMPLICATIONS OF METAPHYSEAL SLEEVES IN REVISION TOTAL KNEE ARTHROPLASTY (RTKA) WITH SEVERE METAPHYSEAL BONE LOSS, AIMING TO EVALUATE THEIR EFFICACY OVER A MINIMUM FOUR-YEAR FOLLOW-UP. A TOTAL OF 29 PATIENTS (8 MALE AND 21 FEMALE) WHO UNDERWENT RTKA WITH ANDERSON ORTHOPAEDIC RESEARCH INSTITUTE (AORI) TYPE II OR III BONE DEFECTS USING POROUS COATED TIBIAL AND/OR FEMORAL METAPHYSEAL SLEEVES FROM DECEMBER 2016 AND JANUARY 2019 WERE INCLUDED IN THE STUDY. PATIENTS HAD A MEAN AGE OF 62.6 YEARS (RANGE: 50-75 YEARS) AT THE TIME OF SURGERY. ALL PATIENTS RECEIVED THE SIGMA TC3 REVISION KNEE SYSTEMS (DEPUY SYNTHES, WARSAW, USA) AS PART OF THEIR REVISION TKA. THE UNDERLYING CAUSE FOR THE PRIMARY TOTAL KNEE ARTHROPLASTY (TKA) WAS MAINLY PRIMARY OSTEOARTHRITIS, ACCOUNTING FOR 26 CASES (89.7%). PRIMARY TKA IMPLANT MANUFACTURER DETAILS WERE AS FOLLOWS: DEPUY (N=8), OPTETRAK (N=8) MERIL (N=6), ZIMMER (N=4), BUECHEL PAPPAS (N=2), AND SMITH & NEPHEW (N=1). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES UNKNOWN KNEE CONSTRUCTS AND SIGMA TC3 REVISION KNEE SYSTEMS OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: PALACOS R+G ANTIBIOTIC CEMENT (HERAEUS MEDICAL) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE CONSTRUCT (QTY (B)(4): 8 PATIENTS, WHO HAD A PRIMARY TKA USING DEPUY, UNDERWENT REVISION TOTAL KNEE ARTHROPLASTY (RTKA) USING SIGMA TC3 REVISION KNEE SYSTEMS DUE TO REASONS UNSPECIFIED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE CONSTRUCT SIGMA (QTY (B)(4): 2 PATIENTS HAD TIBIAL STEM TIP PAIN, SPECIFICALLY THOSE WHO RECEIVED A TIBIAL STEM OF 115 MM IN LENGTH. THIS CONDITION WAS RESOLVED BY THE FINAL FOLLOW-UP, HAVING BEEN MANAGED CONSERVATIVELY USING NSAIDS ADMINISTERED AS NEEDED FOR PAIN ALLEVIATION. 4 PATIENTS EXPERIENCED POST-OPERATIVE RECURRENT PERIPROSTHETIC JOINT INFECTION (PJI), NECESSITATING DEBRIDEMENT AND POLYETHYLENE EXCHANGE (DAIR) ALONG WITH A 6-WEEK REGIMEN OF ANTIBIOTICS, TAILORED TO THE CULTURE AND SENSITIVITY RESULTS. SUBSEQUENTLY, THESE PATIENTS RECOVERED COMPLETELY, WITH NO EVIDENCE OF RESIDUAL INFECTION. 2 PATIENTS HAD PROLONGED WOUND HEALING AND STAPLE REMOVAL. THESE CASES WERE SUCCESSFULLY MANAGED THROUGH CONSERVATIVE MEANS, SPECIFICALLY WITH REGULAR DRESSING CHANGES, AND DID NOT REQUIRE ANTIBIOTIC THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2601120 UNKNOWN KNEE CONSTRUCT SIGMA PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention