BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL TRAY

    MDR report key: 9171573 · Received October 9, 2019

    Report

    Report Number
    1818910-2019-108115
    Event Type
    Injury
    Date Received
    October 9, 2019
    Date of Event
    January 1, 2012
    Report Date
    September 24, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: PATIENT CODE 3191- TO CAPTURE JOINT INSTABILITY.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. THE COMPLAINT WAS RECEIVED INTO THE COMPANY IN THE FORM OF A LITERATURE PAPER WITH THE FOLLOWING COMMENT: LITERATURE ARTICLE RECEIVED TITLED, " DOES OBESITY INFLUENCE CLINICAL OUTCOME AT NINE YEARS FOLLOWING TOTAL KNEE REPLACEMENT" LITERATURE ARTICLE "DOES OBESITY INFLUENCE CLINICAL OUTCOME AT NINE YEARS FOLLOWING TOTAL KNEE REPLACEMENT?" (2012) BY (B)(6) PUBLISHED BY THE JOURNAL OF BONE AND JOINT SURGERY DOI:1302/0301-620X.94B10.28894. NO PRODUCTS WERE RECEIVED AND NO FURTHER PRODUCT INFORMATION WAS RECEIVED. THE LITERATURE PAPER WAS FORWARDED TO CLINICAL SPECIALISTS FOR REVIEW. THEY COMMENTED: THE ARTICLE PURPOSE: TO EVALUATE THE INFLUENCE OF OBESITY ON CLINICAL OUTCOMES AT NINE YEARS FOLLOWING PRIMARY TKR. BETWEEN OCTOBER 1998 AND MARCH 2001, 445 CONSECUTIVE PRIMARY TKRS WERE CARRIED OUT ON 395 PATIENTS USING THE PRESS FIT CONDYLAR (PFC) SIGMA PROSTHESIS AT VICTORIA HOSPITAL, KIRKCALDY. PATIENTS WERE REVIEWED CLINICALLY AND RADIOLOGICALLY AT SIX AND 18 MONTHS AND THREE, FIVE, AND NINE YEARS POST-OPERATIVELY. ALL PRE-OPERATIVE DATA, PERI-OPERATIVE COMPLICATIONS, AND KNEE SOCIETY SCORES WERE PROSPECTIVELY RECORDED. PATIENTS WERE DIVIDED INTO NON-OBESE (BMI < 30 KG/M2 ) AND OBESE (BMI = 30 KG/M2 ) GROUPS. THE OBESE GROUP WAS FURTHER DIVIDED INTO MILDLY OBESE (BMI 30 TO 35 KG/M2 ) AND HIGHLY OBESE (BMI = 35 KG/M2 ) GROUPS. A TOTAL OF 50 PATIENTS (60 TKRS) WERE LOST TO FOLLOW-UP AND WERE EXCLUDED FROM THE ANALYSIS. THE STUDY SAMPLE THEREFORE COMPRISED THE REMAINING 345 PATIENTS. NO SIGNIFICANT DIFFERENCE WAS FOUND IN THE RATE OF PERI-OPERATIVE COMPLICATIONS, REVISION OR IMPLANT SURVIVAL BETWEEN OBESE AND NON-OBESE PATIENTS NINE YEARS AFTER TKR. NO DIFFERENCES IN PERI-OPERATIVE COMPLICATION RATES WERE FOUND BETWEEN OBESE AND NON-OBESE PATIENTS. CEMENT USAGE WAS NOT MENTIONED AND THE PATELLA WAS RESURFACED ACCORDING TO SURGEON'S DISCRETION. COMPLICATIONS NOTED: SUPERFICIAL INFECTIONS (29), DEEP INFECTIONS (8), DEEP VEIN THROMBOSIS (9), PERI-OPERATIVE MORTALITIES (4), AND REVISION SURGERIES (10). THE PERI-OPERATIVE MORTALITIES WERE DUE TO LOBAR PNEUMONIA, SEPTIC SHOCK, STROKE, PNUEMONIA, AND PULMONARY EMBOLISM. THE REVISION SURGERIES WERE DUE TO DEEP INFECTION (6), ONE FOR LOOSENING, TWO FOR POLYETHYLENE WEAR, AND ONE FOR INSTABILITY. DEPUY PRODUCTS INVOLVED: PFC SIGMA TOTAL KNEE SYSTEM WITHOUT RETURNED PARTS, NO FURTHER INVESTIGATION OF THE ASSOCIATED PRODUCTS CAN BE MADE. NO INVESTIGATION AS TO MANUFACTURING DEFECTS CAN BE MADE WITHOUT PRODUCT CODES AND BATCH NUMBERS. POST-MARKET SURVEILLANCE IS PER SEP-419. NO INFORMATION RECEIVED WITH THIS INDIVIDUAL COMPLAINT INDICATED THAT A BROADER INVESTIGATION OR CORRECTIVE ACTION WAS NECESSARY. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : NULL. DEVICE HISTORY BATCH : NULL. DEVICE HISTORY REVIEW : NULL.

    Additional Manufacturer Narrative · 1

    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. 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. - ATTACHMENT: (B)(4).

    Description of Event or Problem · 1

    LITERATURE ARTICLE RECEIVED TITLED, " DOES OBESITY INFLUENCE CLINICAL OUTCOME AT NINE YEARS FOLLOWING TOTAL KNEE REPLACEMENT". LITERATURE ARTICLE "DOES OBESITY INFLUENCE CLINICAL OUTCOME AT NINE YEARS FOLLOWING TOTAL KNEE REPLACEMENT?" (2012) BY R. A. COLLINS, P. J. WALMSEY, A. K. AMIN, I. J. BRENKEL, AND R. A. E. CLAYTON PUBLISHED BY THE JOURNAL OF BONE AND JOINT SURGERY DOI:1302/0301-620X.94B10.28894 WAS REVIEWED FOR MDV REPORTABILITY. THE ARTICLE PURPOSE: TO EVALUATE THE INFLUENCE OF OBESITY ON CLINICAL OUTCOMES AT NINE YEARS FOLLOWING PRIMARY TKR. BETWEEN OCTOBER 1998 AND MARCH 2001, 445 CONSECUTIVE PRIMARY TKRS WERE CARRIED OUT ON 395 PATIENTS USING THE PRESS FIT CONDYLAR (PFC) SIGMA PROSTHESIS AT VICTORIA HOSPITAL, KIRKCALDY. PATIENTS WERE REVIEWED CLINICALLY AND RADIOLOGICALLY AT SIX AND 18 MONTHS AND THREE, FIVE, AND NINE YEARS POST-OPERATIVELY. ALL PRE-OPERATIVE DATA, PERI-OPERATIVE COMPLICATIONS, AND KNEE SOCIETY SCORES WERE PROSPECTIVELY RECORDED. PATIENTS WERE DIVIDED INTO NON-OBESE (BMI < 30 KG/M2 ) AND OBESE (BMI = 30 KG/M2 ) GROUPS. THE OBESE GROUP WAS FURTHER DIVIDED INTO MILDLY OBESE (BMI 30 TO 35 KG/M2 ) AND HIGHLY OBESE (BMI = 35 KG/M2 ) GROUPS. A TOTAL OF 50 PATIENTS (60 TKRS) WERE LOST TO FOLLOW-UP AND WERE EXCLUDED FROM THE ANALYSIS. THE STUDY SAMPLE THEREFORE COMPRISED THE REMAINING 345 PATIENTS. NO SIGNIFICANT DIFFERENCE WAS FOUND IN THE RATE OF PERI-OPERATIVE COMPLICATIONS, REVISION OR IMPLANT SURVIVAL BETWEEN OBESE AND NON-OBESE PATIENTS NINE YEARS AFTER TKR. NO DIFFERENCES IN PERI-OPERATIVE COMPLICATION RATES WERE FOUND BETWEEN OBESE AND NON-OBESE PATIENTS. CEMENT USAGE WAS NOT MENTIONED AND THE PATELLA WAS RESURFACED ACCORDING TO SURGEON'S DISCRETION. COMPLICATIONS NOTED: SUPERFICIAL INFECTIONS (29), DEEP INFECTIONS (8), DEEP VEIN THROMBOSIS (9), PERI-OPERATIVE MORTALITIES (4), AND REVISION SURGERIES (10). THE PERI-OPERATIVE MORTALITIES WERE DUE TO LOBAR PNEUMONIA, SEPTIC SHOCK, STROKE, PNEUMONIA, AND PULMONARY EMBOLISM. THE REVISION SURGERIES WERE DUE TO DEEP INFECTION (6), ONE FOR LOOSENING, TWO FOR POLYETHYLENE WEAR, AND ONE FOR INSTABILITY. DEPUY PRODUCTS INVOLVED: PFC SIGMA TOTAL KNEE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964342 UNKNOWN KNEE TIBIAL TRAY KNEE TIBIAL TRAY JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention