MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3DKNEE; INSERT, 3D EX SZ 6LT 9MM

Model Number	391-09-706
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being reported after learning about a potential device related event following a review of clinical study records.The internal standard operating procedure for complaint reporting has been updated to reflect a requirement for all clinical study events to be handled in the same manner as all product complaints.
Event or Problem Description
Reported incident - due to left knee instability.
Additional Manufacturer Narrative
This mdr is to be voided due to it being a duplicate complaint.

• Brand Name: 3DKNEE
• Common Device Name: INSERT, 3D EX SZ 6LT 9MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7397362
• Report Number: 1644408-2018-00296
• Device Sequence Number: 18852977
• Product Code: OIY
• UDI-Device Identifier: 00888912118965
• UDI-Public: (01)00888912118965
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091956
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2018

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 Model Number: 391-09-706
• Device Catalogue Number: 391-09-706
• Device Lot Number: 59602664
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 04/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 130-03-735, LOT 156N1011; 233-01-106, LOT 890A1271; 333-01-106, LOT 271B1082
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 76