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

Model Number 391-09-706

Device Problem Unstable (1667)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2013

Event Type  Injury  

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 Description

Reported incident - due to left knee instability.

Manufacturer Narrative

This mdr is to be voided due to it being a duplicate complaint.

• Brand Name: 3DKNEE
• Type of Device: INSERT, 3D EX SZ 6LT 9MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7397362
• MDR Text Key: 104402388
• Report Number: 1644408-2018-00296
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00888912118965
• UDI-Public: (01)00888912118965
• Combination Product (y/n): N
• PMA/PMN Number: K091956
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 02/14/2018
• Initial Date FDA Received: 04/04/2018
• Supplement Dates Manufacturer Received: 04/05/2018
• Supplement Dates FDA Received: 04/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 130-03-735, LOT 156N1011; 233-01-106, LOT 890A1271; 333-01-106, LOT 271B1082
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 76