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

Catalog Number 114905

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 02/01/2016

Event Type  Injury  

Event Description

Revision surgery - the patient had a total shoulder implanted after the initial elbow was implanted.There was some interference with the distal end of the shoulder implant stem and the proximal portion of the elbow stem on the humeral side.In (b)(6) 2013, a revision was done where the surgeon had to cut the proximal portion of the elbow humeral stem to make it fit better, so there was no interference with the shoulder implant.The patient has experienced some loosening with the elbow humeral component.The surgeon removed the old humeral component and condyle implants from the elbow.Placed a strut on the distal end of the humerus, cut a new 4 x 100 humeral elbow component cemented it into place and put new condyle components.In.

Manufacturer Narrative

The reason for this revision surgery was implant loosening; the patient had a total shoulder put in after the initial elbow was put in.There was some interference with the distal end of the shoulder implant stem and the proximal portion of the elbow stem on the humeral side.The implant in-vivo length of patient service is unknown but the (b)(4) date would indicate the in-vivo time of approximately 3 years.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.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 device was disposed of at the hospital and not made available to (b)(4) for examination.A review of the device history record and investigation history was not conducted since a lot number was not provided or could be established for the original explanted part.A search the (b)(4) patient database was not conducted since biomet products and surgeries are not included at this time in the historical records.This event is deemed to be non-product related.The root cause for the elbow stem loosening was not reported.No other conditions relating to this event could be determined with confidence.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: BIOMET DISCOVERY ELBOW
• Type of Device: DISC HUM 4X100MM RT FLANGED C
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445 ; 5128346255
• MDR Report Key: 5471956
• MDR Text Key: 39423161
• Report Number: 1644408-2016-00081
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2016
• 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): Other; Required Intervention
• Patient Age: 58 YR