MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. 3DKNEE; INSERT, 3D EX SZ 7RT 13MM

Catalog Number 392-13-707

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 04/29/2015

Event Type  Injury  

Event Description

Revision surgery - due to the surgeon having to perform a retinaculum enclosure.

Manufacturer Narrative

The reason for this revision surgery was the surgeon had to go in and perform a retinaculum enclosure.The length of in vivo service was 6.7 months.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.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 (b)(4) 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 first complaint against this part and lot number.This event is deemed as non-product related.This event and revision surgery is the result of the surgeon determining that he needed perform a retinaculum enclosure for the patient's knee.No other conditions relating to this event could be determined with confidence.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: 3DKNEE
• Type of Device: INSERT, 3D EX SZ 7RT 13MM
• 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: 4756884
• MDR Text Key: 5887850
• Report Number: 1644408-2015-00257
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 392-13-707
• Device Lot Number: 59604586
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2014
• 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: 70 YR