BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL STEM

    MDR report key: 10931585 · Received December 2, 2020

    Report

    Report Number
    1818910-2020-25914
    Event Type
    Injury
    Date Received
    December 2, 2020
    Date of Event
    September 21, 2019
    Report Date
    November 19, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT NUMBER WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS, THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). WHERE THE LOT CODE WAS PROVIDED, A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE LITERATURE ARTICLE TITLED, "METAPHYSEAL SLEEVES IN REVISION TOTAL KNEE ARTHROPLASTY PROVIDE RELIABLE FIXATION AND EXCELLENT MEDIUM TO LONG-TERM IMPLANT SURVIVORSHIP" WRITTEN BY BENJAMIN V. BLOCH, BSC (HONS), MBBS, FRCS (TR & ORTH), ODEI A. SHANNAK, MBBS, FRCS (TR & ORTH), JEYA PALAN, BSC (HONS), MBBS, FRCS (TR & ORTH), JONATHAN R.A. PHILLIPS, MBCHB, MSC, FRCS (TR & ORTH) , AND PETER J. JAMES, BMEDSCI, BMBS (HONS), DIPBIOMECH, FRCS, FRCS (TR & ORTH) PUBLISHED BY THE JOURNAL OF ARTHROPLASTY MADE AVAILABLE ONLINE 21 SEPTEMBER 2019 WAS REVIEWED. THE ARTICLE'S PURPOSE WAS TO RETROSPECTIVELY ANALYZE 319 REVISION TKIAS WITH USE USE OF METAPHYSEAL SLEEVE THAT WERE FOLLOWED FOR AT LEAST 2 YEARS. ALL PATIENTS RECEIVED A REVISION PROSTHESIS FROM DEPUY. TABLE 3 PROVIDES PATIENT IDENTIFIERS AND DETAILS FOR 5 PATIENTS THAT REQUIRED RE-REVISION OR COMPONENT EXCHANGE. ORIGINAL IMPLANTS WERE NOT IDENTIFIED. CEMENT MANUFACTURER NOT IDENTIFIED. PATELLAR RESURFACING WAS NOT DISCUSSED. FIGURE 3 PROVIDES RADIOGRAPHIC IMAGES WITH INDICATION OF INITIAL TIBIAL TRAY SUBSIDENCE AT 1 YEAR BUT NON PROGRESSIVE AND KNEE "FUNCTIONS WELL" AT 5 YEARS ACCORDING TO CAPTION DESCRIPTION. ADVERSE EVENTS: PATIENT (B)(6) YO MALE WITH SROM NOILES (FEMORAL AND TIBIAL SLEEVES USED) CONSTRUCT REQUIRED RE-REVISION DUE TO INFECTION 90 MONTHS STATUS POST INITIAL REVISION SURGERY (ALL IMPLANTS EXPLANTED). PATIENT (B)(6) YO MALE WITH TC3-RP (TIBIAL SLEEVE USED) CONSTRUCT REQUIRED RE-REVISION DUE TO INFECTION 13 MONTHS STATUS POST INITIAL REVISION SURGERY (ALL IMPLANTS EXPLANTED). PATIENT (B)(6) YO FEMALE WITH TC3-RP (TIBIAL SLEEVE USED) CONSTRUCT REQUIRED RE-REVISION DUE TO INFECTION 2 MONTHS STATUS POST INITIAL REVISION SURGERY (ALL IMPLANTS EXPLANTED). PATIENT (B)(6) YO FEMALE WITH SROM NOILES (FEMORAL AND TIBIAL SLEEVES USED) CONSTRUCT REQUIRED INTERVENTION (DEBRIDEMENT, ANTIBIOTICS) DUE TO INFECTION 18 MONTHS STATUS POST INITIAL REVISION SURGERY (IMPLANT RETAINED). PATIENT (B)(6) YO MALE WITH TC3-RP (FEMORAL AND TIBIAL SLEEVES USED) REQUIRED RE-REVISION DUE TO JOINT INSTABILITY (NOTE OF UNDERSIZED FEMUR AND JOINT LINE ELEVATED) 38 MONTHS STATUS POST INITIAL REVISION SURGERY (UNKNOWN WHICH IMPLANTS WERE REVISED OR RETAINED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397123 UNKNOWN KNEE TIBIAL STEM KNEE TIBIAL STEM JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention