MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. BIOMET DISCOVERY ELBOW; DISC HUM 6X100MM RT FLANGED C

Catalog Number 114909

Device Problem Fracture (1260)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 03/10/2016

Event Type  Injury  

Event Description

Revision surgery due to the patient falling and causing a periprosthetic fracture.

Manufacturer Narrative

The reason for this revision surgery was a ulna fracture.The in-vivo length of patient implant service is unknown without the original surgery date which is unknown or not established.The healthcare professional indicated 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 djo surgical for examination.A review of the device history record revealed no issues in the manufacture of this product.A search the djo surgical 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 complaint states the patient fell and caused a peri-prosthetic fracture.The scope is limited since the part (s) associated with the complaint was not returned to djo surgical for evaluation.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 6X100MM 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: 5551840
• MDR Text Key: 41998456
• Report Number: 1644408-2016-00196
• 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: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114909
• Device Lot Number: 231740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2016
• 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): Required Intervention
• Patient Age: 68 YR