BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALL POLY PATELLA CEMENTED 29 MM DIAMETER

    MDR report key: 6180434 · Received December 16, 2016

    Report

    Report Number
    0002648920-2016-04384
    Event Type
    Injury
    Date Received
    December 16, 2016
    Date of Event
    May 27, 2016
    Report Date
    July 14, 2017
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    PK113369
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4). THIS REPORT IS NUMBER 2 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1822565-2016-04384, 04386, 04672, 04691).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL DEVICES: ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) LEFT 10 MM HEIGHT CATALOG# 42511200410 LOT# 62467881; TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE D CATALOG# 42532006701 LOT # 62788548; FEMUR CEMENTED CRUCIATE RETAINING (CR) NARROW LEFT SIZE 6 CATALOG# 42502006001 LOT# 62459367. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. REVIEW OF PRIMARY OPERATIVE NOTES DOES NOT INDICATE ROOT CAUSE. EXAMINATION OF THE KNEE SHOWED GOOD RANGE OF MOTION AND STABILITY AND GOOD PATELLAR TRACKING. THE PATIENT UNDERWENT A MANIPULATION FOR STIFFNESS AND PAIN. THE X-RAYS TAKEN FOR THE LEFT KNEE DEMONSTRATED LEFT KNEE TOTAL REPLACEMENT ARTICULATING ALIGNMENT WITHOUT ANY SIGN OF LUCENCY OR FRACTURE. THE REVISION OPERATIVE NOTES PROVIDED CONFIRM THAT THE PATIENT UNDERWENT REVISION DUE TO FAILED LEFT KNEE ARTHROPLASTY WITH PAIN AND CONTRACTURE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THIS EVENT WAS FILED ON MULTIPLE MDRS. PLEASE ALSO REFERENCE: 0001822565-2016-04672, 0001822565-2016-04691, 0002648920-2016-04386

    Description of Event or Problem · 1

    PATIENT REPORTED UNDERGOING LEFT KNEE MANUAL MANIPULATION 2 MONTHS POST-IMPLANTATION AND REVISION 17 MONTHS POST-IMPLANTATION DUE PAIN, SWELLING, LIMITED RANGE OF MOTION, AND UNSPECIFIED BACK PROBLEMS. ADDITIONAL INFORMATION RECEIVED IN MEDICAL RECORDS INDICATE THE PATIENT EXPERIENCED LEFT KNEE PAIN, ARTHROFIBROSIS, STIFFNESS AND CONTRACTURE POST-IMPLANTATION. PATIENT'S REVISION OPERATIVE REPORT NOTES THAT DURING THE REVISION, ALL COMPONENTS WERE REMOVED AND REPLACED WITH COMPETITOR TOTAL KNEE COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831764 ALL POLY PATELLA CEMENTED 29 MM DIAMETER PROSTHESIS, KNEE JWH ZIMMER MANUFACTURING B.V. N/A 62562114

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R