BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL COMPONENT STEMMED PRECOAT SIZE 5

    MDR report key: 6428875 · Received March 23, 2017

    Report

    Report Number
    0002648920-2017-00205
    Event Type
    Injury
    Date Received
    March 23, 2017
    Report Date
    April 3, 2017
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: THE EVENT OCCURRED SOMETIME IN 2016. MEDICAL PRODUCT: NEXGEN CR-FLEX PRECOAT FEMORAL CATALOG #: 00-5950-016-01 LOT #: 62124280, NEXGEN CR/CR-FLEX/CRA ARTICULAR SURFACE CATALOG #: 90-5970-040-10 LOT #: 61971376, NEXGEN ALL-POLY PATELLA CATALOG #: 00-5972-065-32 LOT #: 62131539 THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS (NOT EXPLANTED); HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3007963827-2017-00033, 0001822565-2017-01869, 0002648920-2017-00206. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORDS FOR PART #00595001601 LOT #62124280 WERE REVIEWED AND ONE ANOMALY WAS IDENTIFIED. A NONCONFORMANCE WAS IDENTIFIED AT THE SONIC CLEANING OPERATION . FOUR ITEMS WERE SCRAPPED DUE TO INCLUSIONS AND STRESS CRACKS. THE DEVICE HISTORY RECORDS FOR PART #00597206532 LOT #62131539 WERE REVIEWED AND NO DEVIATIONS OR ANOMALIES WERE IDENTIFIED. THE DEVICE HISTORY RECORDS FOR THE 00597206532, LOT # 62131539 ERE REVIEWED AND NO DEVIATIONS OR ANOMALIES WERE IDENTIFIED. THE DEVICE HISTORY RECORDS FOR PART #90597004010 LOT #61971376 WERE REVIEWED AND ONE ANOMALY WAS IDENTIFIED. A NONCONFORMANCE WAS IDENTIFIED AT THE PACKAGING OPERATION FOR HANDLING DAMAGE OF TWO ARTICULAR SURFACES THAT WERE THEN SCRAPPED. THE DEVICE HISTORY RECORDS FOR PART #00598004701 LOT #62104548 WERE REVIEWED AND ONE ANOMALY WAS IDENTIFIED. A NONCONFORMANCE WAS IDENTIFIED AT THE DIMENSIONAL INSPECTION OPERATION. THE NUMBER OF PIECES INSPECTED WAS NOT PER THE SAMPLING PLAN SO EXTRA JOB STEPS WERE ADDED TO PERFORM A PROPER INSPECTION. THE IDENTIFIED NON-CONFORMANCES DID NOT HAVE ANY EFFECT ON THE REPORTED ISSUE. A COMPLAINT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINT FOR ANY OF LOT #62124280, LOT #62104548, LOT #61971376, OR LOT #62131539. PRIMARY SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENT WAS IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. THE PATIENT RECEIVED A LEFT KNEE MANIPULATION UNDER ANESTHESIA ABOUT A YEAR POST SURGERY. A RADIOLOGIC REPORT ABOUT THREE YEARS POST SURGERY STATES THAT THERE IS NO CONVINCING EVIDENCE FOR ARTHROPLASTY LOOSENING IN THE LEFT KNEE AND NO JOINT EFFUSION OBSERVED. PER THE PACKAGE INSERTS OF THE COMPONENTS, PAIN IS KNOWN AS A POTENTIAL ADVERSE EFFECT OF THE TKA PROCEDURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS COMPLAINING OF KNEE PAIN 3.5 YEARS AFTER TKA OF THE LEFT KNEE AND 2.5 YEARS AFTER TKA OF THE RIGHT KNEE. THE PATIENT EXPERIENCED INFECTION 3 DAYS POST-SURGERY AFTER THE RIGHT TKA, AND AN X-RAY REVEALED LOOSENING OF THE RIGHT FEMORAL COMPONENT TWO YEARS POST-SURGERY, BUT NO LOOSENING ON THE LEFT SIDE. THE PATIENT IS UNDER PAIN MEDICATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211408 TIBIAL COMPONENT STEMMED PRECOAT SIZE 5 KNEE PROSTHESIS JWH ZIMMER MANUFACTURING B.V. 62104548

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S