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 Code Available (3191)

Event Date 06/06/2016

Event Type  Injury  

Event Description

Revision surgery - due to the patient fracturing their elbow and the implant becoming loose.

Manufacturer Narrative

The reason for this revision surgery was the patient fractured their elbow and the implant became loose.The length of in-vivo service is unknown since the original surgery date was not provided with the complaint and could not be established.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 (dhr) was not conducted since a lot number was not provided or could be determined.Multiple searches of the (b)(4) records and patient database produced no additional information concerning this event.The complaint investigation history records were reviewed and no trends or on-going issues were deemed as present or in need of review.This complaint is non-product related.The root cause for the implant becoming loose was reported as an elbow fracture.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.

Manufacturer Narrative

Additional information was requested from zimmer-biomet based on patient name.After receipt of new information, it was determined that this complaint is a duplicate of (b)(4) that was assigned medical device report number (mdr)# 1644408-2016-00422.Mdr 1444408-2016-00526 is being voided and the complaint will be closed with a quantity of 0 on the affected items.

• 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
• 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: 5799746
• MDR Text Key: 49743407
• Report Number: 1644408-2016-00526
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912225472
• UDI-Public: (01)00888912225472
• 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,Followup
• Report Date: 06/06/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/06/2016
• Initial Date FDA Received: 07/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/27/2016; 10/04/2016
• 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: 62 YR