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

Catalog Number 114700

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 11/10/2016

Event Type  Injury  

Event Description

Revision surgery - due to an infection; with a staged revision.Stage 1 was performed on (b)(6) 2016 and was the removal of the poly and condyle and the insertion of antibiotic beads.The original surgery took place 6 to 7 years prior.Stage 2 of the surgery was on (b)(6) 2016 and was the removal of the antibiotic beads and reimplantation of poly and condyles.

Manufacturer Narrative

The reason for this revision surgery was a staged revision due to an infection.Stage 1 was performed (b)(6) 2016 and was the removal of a poly and condyle and insertion of antibiotic beads.Stage 2 of surgery on (b)(6) 2016 was the removal of the antibiotic beads and reimplantation of poly and condyles.The original surgery took place 6 to 7 years prior; the exact date of the original surgery is unknown.The healthcare professional indicated there was no delay in surgery and the revision surgery was completed as intended.The device was disposed of at the hospital and not made available to (b)(4) for examination.The lot numbers of the devices involved in this event were not provided.To adequately investigate this event, the lot numbers are necessary.In addition to the lot numbers not being supplied, information regarding cultures identified in the infection and the severity of the infection was not supplied.If this information is submitted at a future date, this investigation will be re-evaluated.Attempts were made to obtain the lot numbers of the devices that were removed; however, this information was not available.Without this information, this investigation is limited in scope.The reason of this complaint was a revision surgery due to an infection.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.There are multiple factors that may contribute to an infection that are outside of the control of (b)(4).With the limited information provided about the patient and the devices removed during the revision surgery, it is impossible to determine the source/root cause of the infection.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC CONDYLE KIT W/ HEXALOBULA
• 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: 6187644
• MDR Text Key: 62795391
• Report Number: 1644408-2016-01049
• 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: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/10/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/06/2017
• 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
• Treatment: 114833
• Patient Outcome(s): Required Intervention