BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE

    MDR report key: 4876137 · Received June 29, 2015

    Report

    Report Number
    0001825034-2015-02764
    Event Type
    Injury
    Date Received
    June 29, 2015
    Report Date
    October 25, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN. EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. DATE EXPLANTED - UNKNOWN. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY J.W. GOODFELLOW, C.J. KERSHAW, M.K.D'A BENSON & J.J. O'CONNOR/ BONE JOINT SURG (BR) 1988; 70-B: 692-701 0301-620X/88/5163. MANUFACTURE DATE ¿ UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT AVAILABLE FOR RETURN. ROOT CAUSE COULD NOT BE DETERMINED. RISKS ASSOCIATED WITH REPORTED CONDITION ARE ADDRESSED THROUGH THE WARNINGS IN THE PACKAGE INSERT AS A PART OF DESIGN CONTROL RISK MANAGEMENT. 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, "THE OXFORD KNEE FOR UNICOMPARTMENTAL OSTEOARTHRITIS¿ WHICH ASSESSED THE SURVIVAL OF THE OXFORD KNEE FOR BICOMPARTMENTAL AND UNICOMPARTMENTAL OSTEOARTHRITIS. THE STUDY WAS CONDUCTED OVER A PERIOD OF EIGHT (4) YEARS (NOVEMBER 1982 TO NOVEMBER 1985) AND INVOLVED EIGHTY FIVE (85) PATIENTS WHO RECEIVED ONE-HUNDRED THREE (103) UNICOMPARTMENTAL KNEES. TWO TYPES OF PROCEDURES WERE PERFORMED; WHICH INCLUDED SEVENTY-SIX (76) MEDIAL COMPARTMENT ARTHROPLASTIES AND TWENTY-SEVEN (35) LATERAL COMPARTMENT ARTHROPLASTIES. THE JOURNAL ARTICLE REPORTS THE FOLLOWING REVISIONS: ONE (1) REVISION OF THE MEDIAL COMPARTMENT ARTHROPLASTY DUE TO DEGENERATION IN THE LATERAL TIBIOFEMORAL COMPARTMENT. THREE (3) CASES OF THE MEDIAL COMPARTMENT ARTHROPLASTY INVOLVING ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. ONE (1) REVISION OF THE MEDIAL COMPARTMENT ARTHROPLASTY DUE TO BEARING DISLOCATION. ONE (1) REVISION OF THE LATERAL COMPARTMENT ARTHROPLASTY DUE TO RECURRENT DISLOCATION OF THE BEARING. ONE (1) REVISION OF THE LATERAL COMPARTMENT ARTHROPLASTY DUE TO CHRONIC BEARING. SUBLUXATION OCCURRED, FOLLOWED BY LOOSENING OF THE TIBIAL COMPONENT. TWO (2) CASES OF THE LATERAL COMPARTMENT ARTHROPLASTY INVOLVING MEDIAL SUBLUXATION OF THE BEARING. ONE (1) CASES OF THE LATERAL COMPARTMENT ARTHROPLASTY INVOLVING RECURRENT LOCKING. THE AUTHORS OF THE STUDY CONCLUDE THE OPERATION IS RECOMMENDED FOR KNEES WITH SEVERE UNICOMPARTMENTAL OSTEOARTHRITIS IN WHICH ALL THE LIGAMENTS ARE STILL INTACT. IN THOSE KNEES IN WHICH ALL THE LIGAMENTS WERE INTACT AND WHICH HAD SEVERE UNICOMPARTMENTAL DEGENERATION, REPLACEMENT WITH A UNICOMPARTMENTAL MENISCAL PROSTHESIS HAS PRODUCED PROMISING RESULTS.

    Description of Event or Problem · 1

    ONE PATIENT UNDERWENT ASEPTIC LOOSENING OF TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419949 UNKNOWN KNEE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R