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

Catalog Number 114800

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 08/06/2018

Event Type  Injury  

Event Description

Revision surgery - due to the patient being infected.

Manufacturer Narrative

The reason for this revision surgery was reported as an infection.The time in-vivo of the reported component is unknown as the original surgery date was not provided.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.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.A review of the device history record (dhr) was not conducted since the item and or lot number was not provided or determined during the complaint evaluation.No additional information was obtained to assist in the event identification.As of 14-aug-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 surgeon performed this revision to remedy the patient's condition.This complaint will be closed pending receipt of additional information.No further action is deemed necessary at this time.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 part and or lot number.The only part number and or lot number(s) 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.

• 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: 7773343
• MDR Text Key: 116776548
• Report Number: 1644408-2018-00771
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2018
• 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: 80 YR