MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. 3DKNEE; E-PLUS INSERT, 9MM

Catalog Number 392-09-706

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 12/17/2013

Event Type  Other  

Event Description

Revision surgery - due to instability.

Manufacturer Narrative

The reason for this revision surgery was reported as instability after 1.3 years of patient use.There is no information in this complaint about any patient injuries, activities, accidents, or medical contraindications that may have contributed to the need for revision.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.A review of the device history records showed no non-conforming material reports associated with this product.A review of the product complaint report history showed this is the 2nd complaint for this product (1 stability/poor joint, 1 infection), second for this lot.Root cause for the instability could not be determined with confidence.There is no information reported that showed a material, design, or manufacturing problem with the product.Disposed of.

• Brand Name: 3DKNEE
• Type of Device: E-PLUS INSERT, 9MM
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445 ; 5128346255
• MDR Report Key: 3592611
• MDR Text Key: 4032388
• Report Number: 1644408-2013-00731
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091956
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2017
• Device Catalogue Number: 392-09-706
• Device Lot Number: 596025546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR