MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC CONDYLE KIT WITH HEXALOBULA

Catalog Number 114700

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

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 11/22/2017

Event Type  Injury  

Event Description

Revision surgery - due to the patient having an infection.The surgeon replaced the poly and humeral condyles for a poly revision.

Manufacturer Narrative

The reason for this revision surgery was due to an infection.The date of the original surgery is unknown, therefore the in-vivo length of service can not be determined.There are no reported pre-existing patient health conditions.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 djo surgical for examination.The invoice with the part and lot number of the device involved in this event was not provided.To adequately investigate this event, the part and/or lot number(s) are necessary.In addition to the lot and/or part number not being supplied, information regarding cultures identified in the infection and the severity of the infection was not supplied.The root cause of this complaint was a revision surgery due to an infection.There are multiple factors that may contribute to an infection that are outside of the control of djo surgical.With the limited information provided about the patient and the devices removed during the revision surgery, it is impossible to determine the source of the infection.Containment based on the information submitted with this complaint it is not possible.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC CONDYLE KIT WITH HEXALOBULA
• 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: 7105872
• MDR Text Key: 94470674
• Report Number: 1644408-2017-01143
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912224833
• UDI-Public: (01)00888912224833
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051975
• 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: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR