MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC ULNA 3X155MM RT W BRNG C

Catalog Number 114819

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 10/15/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Third revision surgery - stem broke for the patient ongoing issues with diseased joint causing of stem breakage unknown.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC ULNA 3X155MM RT W BRNG 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: 9295970
• MDR Text Key: 165599688
• Report Number: 1644408-2019-01077
• 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: 11/05/2019

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 Expiration Date: 05/24/2021
• Device Catalogue Number: 114819
• Device Lot Number: 095540
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 11/08/2019
• 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: 114700 LOT 612570
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR