MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3DKNEE; INSERT, 3D SIZE6 X 9MM R DCM 1 POLY INSERT HAD BECOME WORN DUE TO HIGH LE

Catalog Number	392-09-606
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/13/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - the poly insert had become worn due to high level of activity from the patient and it needed to be replaced.No component failure present.
Additional Manufacturer Narrative
The reason for this revision surgery was wear to the poly insert.The date of the original surgery is unknown, the implant in-vivo length of time can not be calculated.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.This investigation is limited in scope as limited information was provided to djo surgical - (b)(4) for review.The lot number of the device involved in this event was not provided.To adequately investigate this event, the part and lot number are necessary.Attempts were made to obtain the lot number of the device that was removed; however, this information was not available.If this information is submitted at a future date, this investigation will be re-evaluated.The root cause of the worn insert was reported as due to the patient's high level of activity.Containment based on the information submitted with this complaint it is not possible as the agent was unable to supply the lot number.If additional information is submitted at a later time, containment will be re-evaluated.The revision surgery was completed successfully.

• Brand Name: 3DKNEE
• Common Device Name: INSERT, 3D SIZE6 X 9MM R DCM 1 POLY INSERT HAD BECOME WORN DUE TO HIGH LE
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6307521
• Report Number: 1644408-2017-00055
• Device Sequence Number: 16401794
• Product Code: JWH
• UDI-Device Identifier: 00888912120173
• UDI-Public: (01)00888912120173
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K020114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 392-09-606
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2017
• Supplement Report FDA Received Date: 03/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR