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

Catalog Number 114700

Device Problem Insufficient Information (3190)

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

Event Date 05/11/2017

Event Type  Injury  

Event Description

Revision surgery - the patient was infected causing revision.

Manufacturer Narrative

Corrected data: the part reported in the initial medical device report was the part implanted during the revision surgery.Manufacturer narrative: the reason for this revision surgery was an infection.The date of the original surgery is unknown, so the length of in-vivo service can not be determined.No information was submitted regarding the patient.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the infection or inhibited the patient's immune system.This investigation is limited in scope as limited information was provided to djo surgical - (b)(4) for review.The part and/or lot number of the device(s) involved in this event was not provided.To adequately investigate this event, the part and/or lot number 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.On 12 may 2017 an agent from evolution medical informed djo surgical - (b)(4) of a revision surgery involving the removal of a (condyle kit).Information about the device(s) that were removed during this revision surgery was not provided.The agent reported "(the patient was infected)" attempts were made to obtain the part and/or lot numbers of the devices that were removed; however, this information was not available.Without this information, this investigation is limited in scope.If additional information can be provided at a later time, this investigation shall be re-evaluated.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 as the agent was unable to supply the lot or part number.It is unknown if the device removed during the revision surgery was a djo surgical device.The only part number provided is that of the device implanted during the revision surgery.If additional information is submitted at a later time, containment will be re-evaluated.The revision surgery was completed successfully.

• 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: 6629608
• MDR Text Key: 77201366
• Report Number: 1644408-2017-00475
• 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: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• 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: 08/09/2017
• 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