MAUDE Adverse Event Report: ENCORE MEDICAL L.P DISCOVERY ELBOW; DISC HUM 4X150MM RT FLANGED C

Catalog Number 114915

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Pain (1994)

Event Date 11/13/2020

Event Type  Injury  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Event Description

Revision surgery - surgeon removed the humeral component and the condyles because the component was obviously loose and causing pain.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC HUM 4X150MM RT FLANGED C
• 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: 10994281
• MDR Text Key: 241258782
• Report Number: 1644408-2020-01131
• Device Sequence Number: 1
• Product Code: JDC
• 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
• Report Date: 12/11/2020

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: 114915
• Device Lot Number: 626350
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/11/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR