BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE

    MDR report key: 4587797 · Received March 10, 2015

    Report

    Report Number
    0001825034-2015-00914
    Event Type
    Injury
    Date Received
    March 10, 2015
    Report Date
    October 25, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WAS NOT PROVIDED FOR THE PATIENTS MENTIONED IN THE JOURNAL ARTICLE. IT IS LIKELY THAT THESE COMPLICATIONS HAVE ALREADY BEEN REPORTED; HOWEVER, IT CANNOT BE DETERMINED BASED ON THE LIMITED INFORMATION MADE AVAILABLE IN THE ARTICLE. SHOULD ADDITIONAL INFORMATION RELATING TO THE EVENTS BE RECEIVED, THE UPDATED INFORMATION WILL BE FORWARDED TO THE FDA. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) AND COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "SECONDARY PATELLAR RESURFACING FOLLOWING TOTAL KNEE ARTHROPLASTY: A COHORT STUDY IN FIFTY EIGHT KNEES WITH A MEAN FOLLOW-UP OF THIRTY ONE MONTHS" WHICH AIMED TO EVALUATE THE MID-TERM CLINICAL OUTCOMES AFTER SECONDARY PATELLAR RESURFACING FOR PERSISTENT ANTERIOR KNEE PAIN (AKP), USING THE AGC KNEE PROSTHESIS, MANUFACTURED AT BIOMET. THE STUDY CONSISTED OF FIFTY-SEVEN (57) PATIENTS WITH FIFTY-EIGHT (58) KNEES WITH PERSISTENT ANTERIOR KNEE PAIN AFTER PRIMARY TOTAL KNEE ARTHROPLASTY THAT REQUIRED SECONDARY PATELLAR RESURFACING BETWEEN (B)(6) 2006 AND (B)(6) 2011. AFTER A MEDIAN FOLLOW-UP OF 31 MONTHS, 42 PATIENTS WERE SATISFIED AND 15 WERE DISSATISFIED REGARDING THE OUTCOME OF THE PROCEDURE. REASONS FOR DISSATISFACTION WERE LITTLE OR NO DECREASE OF ANTERIOR KNEE PAIN OR DECREASED RANGE OF MOTION. THERE WERE 14 OF THE DISSATISFIED PATIENTS WHO EXPERIENCED PAIN. ONE COMPLICATION WAS REGISTERED IN WHICH ONE PATIENT DEVELOPED A LARGE HAEMATOMA POST-OPERATIVELY. SURGICAL DEBRIDEMENT WAS PERFORMED TEN DAYS POSTOPERATIVELY IN THE OPERATION ROOM. IN CONCLUSION, IN PATIENTS WITH PERSISTENT ANTERIOR KNEE PAIN FOLLOWING TOTAL KNEE REPLACEMENT, SECONDARY RESURFACING LEADS TO PATIENT SATISFACTION IN A RELATIVELY LARGE NUMBER OF PATIENTS.

    Description of Event or Problem · 1

    SEVENTY-THREE (73) PATIENTS WERE IDENTIFIED IN THE ARTICLE THAT UNDERWENT SECONDARY PATELLAR RESURFACING DUE TO ANTERIOR KNEE PAIN ON AN UNKNOWN DATE. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165791 UNKNOWN KNEE PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention