MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC ULNA 3X115MM RT W/BRNG C

Catalog Number 114817

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 10/22/2021

Event Type  Injury  

Event Description

Revision surgery - due to loosening.

Manufacturer Narrative

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

Manufacturer Narrative

1644408-2021-01241 was reassessed and determined to be non-reportable.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC ULNA 3X115MM 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: kiersten soderman ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 12798697
• MDR Text Key: 280677962
• Report Number: 1644408-2021-01241
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

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: 114817
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/11/2021
• Supplement Dates Manufacturer Received: 11/15/2021
• Supplement Dates FDA Received: 01/06/2022
• 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: 114915 LOT UNKNOWN; 540-00-000 LOT UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female