BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIM PRIMARY LIPPED TIBIAL BEARING 12 MM THICK X 63/67 MM WIDE

    MDR report key: 6358481 · Received February 24, 2017

    Report

    Report Number
    0001825034-2017-01199
    Event Type
    Injury
    Date Received
    February 24, 2017
    Date of Event
    December 30, 2016
    Report Date
    March 23, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: BMET ARCOM AP PAT 3PST 34MM MD, CATALOG# 11-150842, LOT# 754880; MAXIM ILOK ANA PRI FML 60 RT, CATALOG# 140011, LOT# 562910; BIOMET ILOK PRI TIB TRAY 67MM, CATALOG# 141212, LOT# 606920; BIOMET FINNED PRI STEM 40MM, CATALOG# 141314, LOT# 827700. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE MAY BE NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. REVIEW OF THE DEVICE HISTORY RECORD FOR 146332 LOT 350390 IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES. ONE UNIT WAS SCRAPPED PRIOR TO ORDER RELEASE. THE FOLLOWING COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED: 11-150842, 140011, 141212, 141314, 146332. REVIEW OF COMPLAINT HISTORY FOUND 2 RELATED REPORTS FOR THIS ITEM NUMBER AND NO RELATED REPORTS FOR THIS PART AND LOT COMBINATION. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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

    IT WAS REPORTED PATIENT MAY UNDERGO A REVISION PROCEDURE DUE TO UNKNOWN REASONS. NO REVISION HAS BEEN REPORTED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY SIXTEEN YEARS POST-IMPLANTATION DUE TO POLYETHYLENE WEAR. THE POLYETHYLENE BEARING WAS REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138375 MAXIM PRIMARY LIPPED TIBIAL BEARING 12 MM THICK X 63/67 MM WIDE PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 350390

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention