BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED (LPS) FEMORAL COM

    MDR report key: 1437926 · Received April 27, 2009

    Report

    Report Number
    1822565-2009-00487
    Event Type
    Malfunction
    Date Received
    April 27, 2009
    Date of Event
    March 30, 2009
    Report Date
    April 7, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSH
    Removal / Correction Number
    1822565-04172009-006-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: DURING AN INTERNAL INVESTIGATION, A BUFF LIGHT BOOTH OPERATOR HAD ACCEPTED NON-CONFORMING DEVICES WITH COSMETIC DEFECTS. A NON-CONFORMING BUFFED SURFACE THAT ARTICULATES AGAINST THE PATELLAR OR TIBIAL POLYETHYLENE BEARING SURFACES HAS THE POTENTIAL TO LEAD TO INCREASED POLY WEAR AND POLYETHYLENE DEBRIS GENERATION. EVAL: NO COMPLAINTS OR ADVERSE DEVICE EFFECTS FROM THESE KNEE IMPLANTS HAVE BEEN REPORTED. A VERY LIMITED NUMBER OF THESE DEVICES HAVE BEEN REPORTED TO BE IMPLANTED. THE CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) THAT WERE TAKEN ARE AS FOLLOWS: NEW, INTENSIVE LIGHT BOOTH ON THE JOB TRAINING, NEW LIGHTING AT THE GRIND OPERATION TO CATCH NON-CONFORMANCES UPSTREAM, NEW HANDLING VISUAL AID TO HELP PREVENT HANDLING DAMAGE AFTER BUFFING OPERATION AND EMPLOYEE PRESENTATION TO BRING AWARENESS TO RETURNS AND IMPORTANCE OF REQUIREMENTS. ZIMMER, INC., INITIATED AN INITIAL NOTIFICATION TO THE FIRST CONSIGNEES FOR THE 37 ITEMS BEGINNING VIA PHONE ON 04/17/2009. E-MAIL AND LETTER NOTIFICATIONS WERE SENT COMMENCING 04/22/2009. THE RECALL REPORTING NUMBER IS 1822565-04172009-006-R.

    Description of Event or Problem · 1

    IT IS REPORTED DURING AN INTERNAL INVESTIGATION, A BUFF LIGHT BOOTH OPERATOR HAD ACCEPTED NON-CONFORMING DEVICES WHICH INCLUDED COSMETIC DEFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED (LPS) FEMORAL COM KNEE PROSTHESIS HSH ZIMMER, INC. NA 61207901

    Patients

    Seq Age Sex Outcome Treatment
    1 NA CAT# 00596401751, LOT# 61204820,QTY. 6| POSTERIOR STABILIZED (LSP) FEMORAL COMPONENT| OPTION: CAT# 00596401751, LOT# 61215983, QTY. 4| CAT# 00596401451, LOT# 61219714, QTY. 1| OPTION: CATALOG# 00599601451, LOT# 61207901| NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-| POSTERIOR STABILIZED (LPS) FLEX FEMORAL COMPONENT| NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-| OPTION: CAT# 00596001451, LOT# 61208295, QTY. 5| POSTERIOR STABILIZED (LPS) FLEX FEMORAL COMPONENT| POSTERIOR STABILIZED (LPS) FLEX FEMORAL COMPONENT| NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-| OPTION: CAT# 00596401751, LOT# 61219677, QTY. 5| NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-| TOTAL QTY. 10| POSTERIOR STABILIZED (LPS) FLEX FEMORAL COMPONENT| NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-| NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-| POSTERIOR STABLIZED (LPS) FLEX FEMORAL COMPONENT| OPTION: CAT# 00596401751, LOT# 61219684, QTY. 4| OPTION: CAT# 00596401751, LOT# 61227758, QTY. 2