BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE PATELLA

    MDR report key: 9269525 · Received November 1, 2019

    Report

    Report Number
    1818910-2019-113777
    Event Type
    Injury
    Date Received
    November 1, 2019
    Date of Event
    June 1, 2011
    Report Date
    October 17, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 WAS RECEIVED. ROOT CAUSE UNDETERMINED. 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. 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

    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. (B)(4).

    Description of Event or Problem · 1

    LITERATURE ARTICLE WAS RECEIVED ENTITLED "COMPARISON OF THE LOW CONTACT STRESS AND PRESS FIT CONDYLAR ROTATING-PLATFORM MOBILE-BEARING PROSTHESES IN TOTAL KNEE ARTHROPLASTY". LITERATURE ARTICLE "COMPARISON OF THE LOW CONTACT STRESS AND PRESS FIT CONDYLAR ROTATING-PLATFORM MOBILE-BEARING PROSTHESES IN TOTAL KNEE ARTHROPLASTY" (2011) BY COMPARISON OF THE LOW CONTACT STRESS AND PRESS FIT CONDYLAR ROTATING-PLATFORM MOBILE-BEARING PROSTHESES IN TOTAL KNEE ARTHROPLASTY PUBLISHED BY THE JOURNAL OF BONE AND JOINT SURGERY DOI:10.2106/JBJS.J.00445 WAS REVIEWED. THE ARTICLE PURPOSE: TO DETERMINE WHETHER THE KNEE AND FUNCTION SCORES AND THE RADIOGRAPHIC RESULTS FOR THE KNEES WITH A PFC SIGMA PS-RP PROSTHESIS WOULD BE BETTER THAN THOSE WITH AN LCS RP PROSTHESIS AND WHETHER THE KNEES WITH A PFC SIGMA PS-RP PROSTHESIS WOULD HAVE A BETTER RANGE OF MOTION. THE ARTICLE REPORTS: RANDOMIZATION TO TREATMENT WITH THE LCS RP OR PFC SIGMA PS-RP TOTAL KNEE PROSTHESIS WAS CONDUCTED. IN ALL PROCEDURES, THE FIRST KNEE RECEIVED THE PROSTHESIS INDICATED BY A SEALED ENVELOPE AND THE CONTRALATERAL KNEE RECEIVED THE OTHER PROSTHESIS. THREE KNEES IN THE LCS RP GROUP AND TWO KNEES IN THE PFC SIGMA PS-RP GROUP HAD A DEEP INFECTION AND REQUIRED A TWO-STAGE REVISION. NONE OF THESE FIVE KNEES HAD A RECURRENCE OF INFECTION AT THE TIME OF THE LATEST FOLLOW-UP. ONE KNEE IN THE LCS RP GROUP REQUIRED OPEN REDUCTION AND INTERNAL FIXATION FOR THE TREATMENT OF A SUPRACONDYLAR FRACTURE OF THE FEMUR. TWO KNEES IN THE PFC SIGMA PS-RP GROUP HAD A PATELLAR CLUNK SYNDROME AND REQUIRED ARTHROSCOPIC DEBRIDEMENT, WITH GOOD RESULTS. INSTABILITY DID NOT OCCUR IN ANY KNEE IN EITHER GROUP. THE PREVALENCE OF OSTEOLYSIS WAS 1.9% (TWO KNEES) IN THE LCS RP GROUP AND 2.8% (THREE KNEES) IN THE PFC SIGMA PS-RP GROUP. THE AUTHORS CONCLUDE THAT THERE IS NO STATISTICAL DIFFERENCE BETWEEN THE CLINICAL AND RADIOLOGICAL OUTCOMES OF THE TWO PROSTHESES. ALL IMPLANTS WERE CEMENTED AND PATELLA RESURFACING WAS CONDUCTED IN ALL KNEES. DEPUY PRODUCTS INVOLVED: PFC SIGMA PS-RP AND LCS RP. COMPLICATIONS WITH PFC SIGMA PS-RP: INFECTION (2), PATELLAR CLUNK SYNDROME (2), OSTEOLYSIS (3), SURGICAL INTERVENTION (4), MEDICAL DEVICE IMPLANT REMOVAL (2). COMPLICATIONS WITH LCS RP: INFECTION (3), POST-OP BONE FRACTURE (1), OSTEOLYSIS (2), SURGICAL INTERVENTION (4), MEDICAL DEVICE IMPLANT REMOVAL (3). THE FIRST FOUR PRODUCTS ARE TO CAPTURE THE PFC SIGMA PS-RP COMPONENTS AND THE FOLLOWING FOUR PRODUCTS ARE TO CAPTURE THE LCS RP COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1062809 UNKNOWN KNEE PATELLA KNEE PATELLA JWH DEPUY ORTHOPAEDICS INC US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention