BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL TRAY

    MDR report key: 13598707 · Received February 25, 2022

    Report

    Report Number
    1818910-2022-03556
    Event Type
    Injury
    Date Received
    February 25, 2022
    Date of Event
    September 25, 2020
    Report Date
    February 25, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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). 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. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED TAGLIERO AJ, KURIAN EB, LAPRADE MD, SONG BM, SARIS DBF, STUART MJ, CAMP CL, KRYCH AJ. ARTHRITIC PROGRESSION SECONDARY TO MENISCUS ROOT TEAR TREATED WITH KNEE ARTHROPLASTY DEMONSTRATES SIMILAR OUTCOMES TO PRIMARY OSTEOARTHRITIS: A MATCHED CASE-CONTROL COMPARISON. KNEE SURG SPORTS TRAUMATOL ARTHROSC. 2021 JUN;29(6):1977-1982. DOI: 10.1007/S00167-020-06273-1. EPUB 2020 SEP 25. PMID: 32975627. OBJECTIVE AND METHODS: THE AIM OF THIS 2:1 MATCHED CASE CONTROL SERIES WAS TO COMPARE OUTCOMES IN PATIENTS WHO UNDERWENT ARTHROPLASTY FOR ARTHRITIS FOLLOWING A MENISCUS ROOT TEAR (ROOT TEAR COHORT-"RTC") WITH A CONTROL GROUP OF PATIENTS WITH PRIMARY OSTEOARTHRITIS (PRIMARY OSTEOARTHRITIS-"CONTROLS"). THE AUTHORS HYPOTHESIZED THAT THE MENISCUS ROOT TEAR PATIENTS WOULD HAVE SIMILAR CLINICAL OUTCOMES, RETURN TO ACTIVITY, COMPLICATION AND REOPERATION RATES AS THEIR MATCHED CONTROLS. A CONSECUTIVE SERIES OF 225 PATIENTS WHO HAD A CLINICALLY AND RADIOGRAPHICALLY CONFIRMED MENISCUS ROOT TEAR BETWEEN 2002 AND 2017 INCLUDING 75 ROOT TEAR COHORT PATIENTS (13 UKA, 62 TKA) AND 150 CONTROL PATIENTS. THE PRIMARY TKA PATIENTS RECEIVED A DEPUY ATTUNE, DEPUY PFC SIGMA, OR COMPETITOR CONSTRUCT WITH PATELLAR RESURFACING. THE MANUFACTURERS OF THE UKA AND CEMENT UTILIZED WERE NOT PROVIDED. THE AUTHORS CONCLUDE THAT ARTHROPLASTY CAN BE A RELIABLE OPTION FOR SELECTED PATIENTS WITH AN IRREPARABLE ROOT TEAR AND ONGOING PAIN AND DYSFUNCTION REFRACTORY TO NON-OPERATIVE MANAGEMENT, EVEN IN THE SETTING OF LESS ADVANCED OSTEOARTHRITIS ON X-RAY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ATTUNE, PFC SIGMA, OR COMPETITOR POSTERIOR STABILIZING PRIMARY TKAS WITH PATELLA RESURFACING AS THERE IS INSUFFICIENT INFORMATION PROVIDED TO CAPTURE THE ACTUAL DEVICES REVISED, THIS COMPLAINT WILL CAPTURE ALL OF THE FOLLOWING IPS AND EVENTS WITH THE QUANTITY OF 1 AND FOLLOW UP FOR CLARIFICATION WILL BE CONDUCTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS ASSOCIATED WITH DEPUY DEVICES: LOOSENING OF AN UNKNOWN DEVICE TREATED WITH REVISION. PATELLAR CLUNK TREATED ARTHROSCOPICALLY. ARTHROFIBROSIS TREATED WITH MANIPULATION UNDER ANESTHESIA. TRAUMATIC PATELLAR TENDON RUPTURE TREATED WITH SURGICAL REPAIR. SUPERFICIAL WOUND NECROSIS TREATED WITH I&D. ACUTE INFECTION TREATED WITH REVISION OF UNKNOWN COMPONENTS. SUPERFICIAL WOUND INFECTION- TREATMENT NOT SPECIFIED. PULMONARY EMBOLISM- TREATMENT NOT SPECIFIED. DEEP VEIN THROMBOSIS- TREATMENT NOT SPECIFIED. TERMINAL EXTENSION LOSS- TREATMENT NOT SPECIFIED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED TAGLIERO AJ, KURIAN EB, LAPRADE MD, SONG BM, SARIS DBF, STUART MJ, CAMP CL, KRYCH AJ. ARTHRITIC PROGRESSION SECONDARY TO MENISCUS ROOT TEAR TREATED WITH KNEE ARTHROPLASTY DEMONSTRATES SIMILAR OUTCOMES TO PRIMARY OSTEOARTHRITIS: A MATCHED CASE-CONTROL COMPARISON. KNEE SURG SPORTS TRAUMATOL ARTHROSC. 2021 JUN;29(6):1977-1982. DOI: 10.1007/S00167-020-06273-1. EPUB 2020 SEP 25. PMID: 32975627. OBJECTIVE AND METHODS: THE AIM OF THIS 2:1 MATCHED CASE CONTROL SERIES WAS TO COMPARE OUTCOMES IN PATIENTS WHO UNDERWENT ARTHROPLASTY FOR ARTHRITIS FOLLOWING A MENISCUS ROOT TEAR (ROOT TEAR COHORT-"RTC") WITH A CONTROL GROUP OF PATIENTS WITH PRIMARY OSTEOARTHRITIS (PRIMARY OSTEOARTHRITIS-"CONTROLS"). THE AUTHORS HYPOTHESIZED THAT THE MENISCUS ROOT TEAR PATIENTS WOULD HAVE SIMILAR CLINICAL OUTCOMES, RETURN TO ACTIVITY, COMPLICATION AND REOPERATION RATES AS THEIR MATCHED CONTROLS. A CONSECUTIVE SERIES OF 225 PATIENTS WHO HAD A CLINICALLY AND RADIOGRAPHICALLY CONFIRMED MENISCUS ROOT TEAR BETWEEN 2002 AND 2017 INCLUDING 75 ROOT TEAR COHORT PATIENTS (13 UKA, 62 TKA) AND 150 CONTROL PATIENTS. THE PRIMARY TKA PATIENTS RECEIVED A DEPUY ATTUNE, DEPUY PFC SIGMA, OR COMPETITOR CONSTRUCT WITH PATELLAR RESURFACING. THE MANUFACTURERS OF THE UKA AND CEMENT UTILIZED WERE NOT PROVIDED. THE AUTHORS CONCLUDE THAT ARTHROPLASTY CAN BE A RELIABLE OPTION FOR SELECTED PATIENTS WITH AN IRREPARABLE ROOT TEAR AND ONGOING PAIN AND DYSFUNCTION REFRACTORY TO NON-OPERATIVE MANAGEMENT, EVEN IN THE SETTING OF LESS ADVANCED OSTEOARTHRITIS ON X-RAY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ATTUNE, PFC SIGMA, OR COMPETITOR POSTERIOR STABILIZING PRIMARY TKAS WITH PATELLA RESURFACING AS THERE IS INSUFFICIENT INFORMATION PROVIDED TO CAPTURE THE ACTUAL DEVICES REVISED, THIS COMPLAINT WILL CAPTURE ALL OF THE FOLLOWING IPS AND EVENTS WITH THE QUANTITY OF 1 AND FOLLOW UP FOR CLARIFICATION WILL BE CONDUCTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS ASSOCIATED WITH DEPUY DEVICES: LOOSENING OF AN UNKNOWN DEVICE TREATED WITH REVISION. PATELLAR CLUNK TREATED ARTHROSCOPICALLY. ARTHROFIBROSIS TREATED WITH MANIPULATION UNDER ANESTHESIA. TRAUMATIC PATELLAR TENDON RUPTURE TREATED WITH SURGICAL REPAIR. SUPERFICIAL WOUND NECROSIS TREATED WITH I&D. ACUTE INFECTION TREATED WITH REVISION OF UNKNOWN COMPONENTS. SUPERFICIAL WOUND INFECTION- TREATMENT NOT SPECIFIED. PULMONARY EMBOLISM- TREATMENT NOT SPECIFIED. DEEP VEIN THROMBOSIS- TREATMENT NOT SPECIFIED. TERMINAL EXTENSION LOSS- TREATMENT NOT SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229459 UNKNOWN KNEE TIBIAL TRAY KNEE TIBIAL TRAY NJL DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention