BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE FEMORAL

    MDR report key: 19539250 · Received June 14, 2024

    Report

    Report Number
    1818910-2024-12950
    Event Type
    Injury
    Date Received
    June 14, 2024
    Date of Event
    January 1, 2024
    Report Date
    June 14, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KOUTP A, HAUER G, LEITNER L, KALTENEGGER L, FISCHERAUER S, CLAR C, REINBACHER P, SCHITTEK G, LEITHNER A, SADOGHI P. LESS INDUCTION TIME AND POSTOPERATIVE PAIN USING SPINAL ANESTHESIA VERSUS GENERAL ANESTHESIA WITH OR WITHOUT THE USE OF PERIPHERAL NERVE BLOCKS IN TOTAL KNEE ARTHROPLASTY. J ARTHROPLASTY. 2024 APR;39(4):904-909. DOI: 10.1016/J.ARTH.2023.10.018. EPUB 2023 OCT 16. PMID: 37852447. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KOUTP A, HAUER G, LEITNER L, KALTENEGGER L, FISCHERAUER S, CLAR C, REINBACHER P, SCHITTEK G, LEITHNER A, SADOGHI P. LESS INDUCTION TIME AND POSTOPERATIVE PAIN USING SPINAL ANESTHESIA VERSUS GENERAL ANESTHESIA WITH OR WITHOUT THE USE OF PERIPHERAL NERVE BLOCKS IN TOTAL KNEE ARTHROPLASTY. J ARTHROPLASTY. 2024 APR;39(4):904-909. DOI: 10.1016/J.ARTH.2023.10.018. EPUB 2023 OCT 16. PMID: 37852447. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: OUR AIM WAS TO ANALYZE ANESTHETIC INDUCTION TIME AND POSTOPERATIVE PAIN USING SPINAL ANESTHESIA VERSUS GENERAL ANESTHESIA WITH OR WITHOUT THE USE OF PERIPHERAL NERVE BLOCKS (PNBS) IN TOTAL KNEE ARTHROPLASTY. THE HYPOTHESIS WAS THAT SPINAL ANESTHESIA WOULD BE BENEFICIAL WITH RESPECT TO INDUCTION TIME AND POSTOPERATIVE PAIN AND THAT PNBS WOULD COMPLEMENT THIS EFFECT. METHODS: PATIENTS WERE STRATIFIED ACCORDING TO DEMOGRAPHICS, AMERICAN SOCIETY OF ANESTHESIOLOGISTS PHYSICAL STATUS CLASSIFICATION SYSTEM (ASA), AND OPIOID INTAKE AND DIVIDED INTO: (A) GENERAL ANESTHESIA WITHOUT PNB; (B) GENERAL ANESTHESIA WITH PNB; (C) SPINAL ANESTHESIA WITHOUT PNB; AND (D) SPINAL ANESTHESIA WITH PNB. ENDPOINTS WERE ANESTHETIC INDUCTION TIME, OPIOID CONSUMPTION, AND PAIN. OF 559 PATIENTS, 348 (62.3%) RECEIVED GENERAL ANESTHESIA (CONSISTING OF GROUP A WITH 46 AND GROUP B WITH 302 PATIENTS), AND 211 (37.7%) SPINAL ANESTHESIA (CONSISTING OF GROUP C WITH 117 AND GROUP D WITH 94 PATIENTS). RESULTS: WE OBSERVED SIGNIFICANTLY LOWER TOTAL OPIOID INTAKE 48 HOURS POSTOPERATIVE WHEN APPLYING SPINAL ANESTHESIA BY 2.08 MG (P < .05) OF INTRAVENOUS MORPHINE-EQUIVALENT, AND A REDUCTION OF 7.0 MINUTES (P < .05) UNTIL SKIN INCISION. THE APPLICATION OF A PNB ACHIEVED A REDUCTION OF PIRITRAMIDE INTAKE OF 3.59 MG (P < .05) 48 HOURS POSTOPERATIVE AND LENGTHENED INDUCTION TIME BY 8.5 MINUTES (P < .05). CONCLUSIONS: STATISTICALLY SHORTER ANESTHETIC INDUCTION TIMES WITHOUT CLINICAL RELEVANCE, BUT LOWER POSTOPERATIVE OPIOID DOSAGES WITH CLINICAL RELEVANCE WERE OBSERVED FOR PATIENTS UNDERGOING TOTAL KNEE ARTHROPLASTY WITH SPINAL ANESTHESIA. THE ADDITIONAL APPLICATION OF PNBS LED TO A LOWER NEED FOR OPIOIDS AND LOWER PAIN LEVELS IN THE EARLY POSTOPERATIVE PHASE. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNKNOWN KNEE FEMORAL, UNKNOWN KNEE INSERT, AND UNKNOWN KNEE TIBIAL TRAY ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN KNEE FEMORAL (QTY 47) 1 PATIENT SUSTAINED AN INFECTION REQUIRING A TWO STAGE EXCHANGED FOLLOWED BY AMPUTATION 3 PATIENTS REQUIRED A REVISION DUE TO INFECTION 4 PATIENTS SUSTAINED DVTS WITHOUT AN IDENTIFIED INTERVENTION 6 PATIENTS SUSTAINED PERIPHERAL NERVE-RELATED PROBLEMS WITHOUT AN IDENTIFIED INTERVENTION 1 PATIENT SUSTAINED A SUPERFICIAL SURGICAL SITE INFECTION WITHOUT KNOWN INTERVENTION 2 PATIENTS SUSTAINED POSTOPERATIVE SOFT TISSUE HEMATOMAS WITHOUT KNOWN INTERVENTION 20 PATIENTS SUSTAINED A FALL WITHOUT KNOWN INTERVENTION 10 PATIENTS EXPERIENCED DELIRIUM AND BEHAVIORAL CHANGE POST-OPERATIVELY WITHOUT KNOWN INTERVENTION ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN KNEE INSERT (QTY 48) 1 PATIENT SUSTAINED AN INFECTION REQUIRING A TWO STAGE EXCHANGED FOLLOWED BY AMPUTATION 3 PATIENTS REQUIRED A REVISION DUE TO INFECTION 1 PATIENT REQUIRED A REVISION DUE TO A DISASSOCIATED POLY INSERT 4 PATIENTS SUSTAINED DVTS WITHOUT AN IDENTIFIED INTERVENTION 6 PATIENTS SUSTAINED PERIPHERAL NERVE-RELATED PROBLEMS WITHOUT AN IDENTIFIED INTERVENTION 1 PATIENT SUSTAINED A SUPERFICIAL SURGICAL SITE INFECTION WITHOUT KNOWN INTERVENTION 2 PATIENTS SUSTAINED POSTOPERATIVE SOFT TISSUE HEMATOMAS WITHOUT KNOWN INTERVENTION 20 PATIENTS SUSTAINED A FALL WITHOUT KNOWN INTERVENTION 10 PATIENTS EXPERIENCED DELIRIUM AND BEHAVIORAL CHANGE POST-OPERATIVELY WITHOUT KNOWN INTERVENTION ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN KNEE TIBIAL TRAY (QTY 49) 1 PATIENT SUSTAINED AN INFECTION REQUIRING A TWO STAGE EXCHANGED FOLLOWED BY AMPUTATION 3 PATIENTS REQUIRED A REVISION DUE TO INFECTION 1 PATIENT REQUIRED A REVISION DUE TO A DISASSOCIATED POLY INSERT 1 PATIENT SUSTAINED AN AVULSION FRACTURE OF THE TIBIAL TUBEROSITY WITHOUT AN IDENTIFIED INTERVENTION 4 PATIENTS SUSTAINED DVTS WITHOUT AN IDENTIFIED INTERVENTION 6 PATIENTS SUSTAINED PERIPHERAL NERVE-RELATED PROBLEMS WITHOUT AN IDENTIFIED INTERVENTION 1 PATIENT SUSTAINED A SUPERFICIAL SURGICAL SITE INFECTION WITHOUT KNOWN INTERVENTION 2 PATIENTS SUSTAINED POSTOPERATIVE SOFT TISSUE HEMATOMAS WITHOUT KNOWN INTERVENTION 20 PATIENTS SUSTAINED A FALL WITHOUT KNOWN INTERVENTION 10 PATIENTS EXPERIENCED DELIRIUM AND BEHAVIORAL CHANGE POST-OPERATIVELY WITHOUT KNOWN INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373845 UNKNOWN KNEE FEMORAL KNEE FEMORAL JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention