MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. DISCOVERY ELBOW; DISC ULNA 3X115MM RT W/BRNG C

Catalog Number 114817

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

Patient Problem Unspecified Infection (1930)

Event Date 11/02/2016

Event Type  Injury  

Event Description

Revision surgery - the surgeon preformed a total elbow replacement on (b)(6) 2016 using the discovery elbow.On (b)(6) 2016 the elbow became infected, only the ulna was removed and the elbow was cleaned out.The infection cleared and a new poly was implanted on (b)(6) 2016.

Manufacturer Narrative

This investigation was submitted for the second stage of a two stage process to alleviate a customer infection.The original surgery took place on (b)(6) 2016.The first surgery of the two stage infection treatment was performed on (b)(6) 2016 and the second stage was performed (b)(6) 2016.Refer to (b)(4) for the record of the first stage of the treatment and device history.On (b)(6) 2016 the infection cleared up and a new discovery elbow, dticket no.(b)(4), was implanted in the patient.This event was determined to be a non product related event and is considered a event not caused or created by a djo product.The root cause for this investigation is the development of a patient infection and the surgeon's process to address and alleviate the infection.The discovery elbow, refence (b)(4), was removed on (b)(6) 2016 (b)(4).This event reports the second stage of the process after the infection cleared up.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.The revision surgery was completed successfully.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC ULNA 3X115MM RT W/BRNG C
• 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: 6143152
• MDR Text Key: 61399160
• Report Number: 1644408-2016-00903
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912225175
• UDI-Public: (01)00888912225175
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114817
• Device Lot Number: 452760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR