MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC ULNA BEARING KIT

Catalog Number 114800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 12/08/2017

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was due to pain. It was reported the previous surgery occurred 10 years ago. No records of the previous surgery were forwarded for review. The complaint reports no issues of any other patient injuries, activities, accidents that may have been contributory to this surgery. No reported pre-existing patient health conditions. The complaint reported no surgical delays during the revision surgery. The 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 record (dhr) was not conducted since the lot number was not provided or determined during the complaint evaluation. No additional information was obtained to assist in the event identification. As of (b)(6) 2018, no records have been forwarded by zimmer-biomet concerning this event. Should zimmer-biomet provide additional information concerning this complaint, the complaint will be re-opened and a further review shall be conducted. The root cause of this complaint was a revision surgery due to pain. There are multiple factors that may contribute to an event that are outside of the control of djo surgical. Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.

Event Description

Revision surgery - due to the patient experiencing pain.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC ULNA BEARING KIT
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer Contact: teffany hutto ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 7140059
• MDR Text Key: 262857951
• Report Number: 1644408-2017-01212
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912225083
• UDI-Public: (01)00888912225083
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 114800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/21/2017 Patient Sequence Number: 1