MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC HUM 4X100MM RT FLANGED C

Catalog Number 114905

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision surgery - loosening of the implant possibly by metallosis.

Manufacturer Narrative

D10 - adding concomitant part 402439.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC HUM 4X100MM 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: 9700554
• MDR Text Key: 179243027
• Report Number: 1644408-2020-00098
• 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,Followup,Followup
• Report Date: 05/27/2022

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: 114905
• Device Lot Number: 146810
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 02/18/2020; 02/18/2020
• Supplement Dates FDA Received: 03/17/2020; 05/27/2022
• Was Device Evaluated by Manufacturer?: No
• 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 021120; 114803 LOT 777330; 402439 COBALT-G MV BONE CEMENT 40GM B 247480; 402439 COBALT-G MV BONE CEMENT 40GM B 971990
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female