MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC 5X75MM RIGHT ULNA TRIAL

Catalog Number 414878

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was reported as an infection.The actual length of in-vivo for the items listed is unknown as the original surgery date was not provided or could be established.The healthcare professional indicated there was a significant adverse event to the patient.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The devices were disposed of at hospital and not made available to djo surgical for examination.The revised items was not returned for examination and the item and lot numbers was not provided.To adequately investigate this event, the part and lot numbers are necessary.In addition to the part and 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.Customer complaint history of the reported items showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to an infection.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The surgeon performed this revision to remedy the patient's condition.This complaint will be closed pending receipt of additional information.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Event Description

Revision surgery - patient had a right discovery removed because of infection.Surgeon is planning a 2 stage surgery so put cobalt with gent around new implant components and will remove it in 3 months.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC 5X75MM RIGHT ULNA TRIAL
• 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: 10843883
• MDR Text Key: 216363411
• Report Number: 1644408-2020-01028
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 414878
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2020
• 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: 540-00-000 LOT UNKNOWN; UNK-DISC LOT UNKNOWN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 68 YR