BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL INSERT

    MDR report key: 9163868 · Received October 7, 2019

    Report

    Report Number
    1818910-2019-107952
    Event Type
    Injury
    Date Received
    October 7, 2019
    Date of Event
    November 28, 2015
    Report Date
    September 19, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : NULL. DEVICE HISTORY BATCH : NULL. DEVICE HISTORY REVIEW : NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. (B)(4).

    Description of Event or Problem · 1

    LITERATURE ARTICLE ENTITLED ¿UNCONSTRAINED TOTAL KNEE ARTHROPLASTY IN SIGNIFICANT VALGUS DEFORMITY: A MODIFIED SURGICAL TECHNIQUE TO BALANCE THE KNEE AND AVOID INSTABILITY". LITERATURE ARTICLE "UNCONSTRAINED TOTAL KNEE ARTHROPLASTY IN SIGNIFICANT VALGUS DEFORMITY: A MODIFIED SURGICAL TECHNIQUE TO BALANCE THE KNEE" (2015) BY R. PAGOTI, S. O¿BRIEN, E. DORAN, AND D. BEVERLAND PUBLISHED BY KNEE SURGERY TRAUMATOL ARTHROSE WAS REVIEWED. THE ARTICLE PURPOSE: A MODIFIED SURGICAL TECHNIQUE INVOLVING ADAPTING THE DISTAL FEMORAL CUT WITH MINIMAL SOFT TISSUE RELEASE IS PROPOSED. THE AUTHORS HYPOTHESISE THAT USING THIS TECHNIQUE WOULD RESULT IN SATISFACTORY RADIOLOGICAL AND FUNCTIONAL OUTCOME. THE REPORT SERVES TO INVESTIGATE THE VALIDITY OF THE AUTHOR'S HYPOTHESIS. THE ARTICLE REPORTS: RETROSPECTIVE ANALYSIS OF 276 CONSECUTIVE TKAS PERFORMED USING THIS TECHNIQUE UNDER THE CARE OF A SINGLE SURGEON IN PATIENTS WITH VALGUS KNEE DEFORMITY =10DEGREES WAS UNDERTAKEN. MEDIAN AGE WAS 74 (RANGE, 48¿87 YEARS) WITH 218 FEMALE (83 %) AND 45 MALE (17 %) PATIENTS. MEDIAN BODY MASS INDEX (BMI) WAS 28.7 KG/M2 (RANGE, 18.5¿43.9). PRIMARY DIAGNOSIS WAS OSTEOARTHRITIS IN 251 KNEES (91 %), RHEUMATOID ARTHRITIS IN 20 KNEES (7.2 %) AND INFLAMMATORY OR PSORIATIC ARTHRITIS IN 5 KNEES (1.8 %). ALL COMPONENTS WERE CEMENTLESS, EXCEPT IN TWELVE PATIENTS WHERE BONE WAS CONSIDERED POOR AND CEMENT WAS USED ON THE TIBIAL SIDE. THE PATELLA WAS NEVER RESURFACED AND THE CEMENT MANUFACTURER WAS NOT DISCLOSED. ONE YEAR POST-OPERATIVELY THE MEAN AKS CLINICAL SCORE IMPROVED TO 86.5 (SD 12.2), FROM THE PRE-OPERATIVE SCORE OF 19.1 (SD 15.6). OVERALL, 197 KNEES (71.6 %) HAD EXCELLENT, 54 KNEES (19.6 %) HAD GOOD, 14 KNEES (5 %) HAD FAIR, AND 10 KNEES (3.8 %) HAD POOR RESULTS. COMPLICATIONS: THREE PATIENTS STILL HAD SEVERE PERSISTENT PAIN FOLLOWING THE OPERATION WITH NO OBVIOUS CLINICAL OR RADIOLOGICAL CAUSE FOUND. COMPLICATIONS: EIGHT KNEES REQUIRED READMISSION, NINE PATIENTS HAD SUPERFICIAL WOUND INFECTIONS, THREE PATIENTS HAD DEEP INFECTIONS, ONE PATIENT HAD A HAEMATOMA, ONE PATIENT EXPERIENCED "SPINOUT", ONE PATIENT EXPERIENCED SUBSIDENCE, AND ONE PATIENT EXPERIENCED PATELLAR INSTABILITY ALTHOUGH THE AUTHORS NOTE THAT THIS PATIENT ALSO HAD SEVERE PRE-OPERATIVE PATELLO-FEMORAL INSTABILITY. DEPUY PRODUCTS INVOLVED: LCS RP KNEE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958595 UNKNOWN KNEE TIBIAL INSERT KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS, INC. 1818910

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention