MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC ULNA 2.5X53MM RT BOND CT

Catalog Number 114803

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/05/2018

Event Type  Injury  

Event Description

Second revision surgery - due to the patient having a fracture.The original surgery was done before djo took over discovery elbow product.

Manufacturer Narrative

The reason for this revision surgery was due to a fracture.The original surgery date of the discovery ulna was not provided or could be established, therefore the in-vivo length of service can not be determined.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.There are no reported pre-existing patient health conditions.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 (dhr) was not conducted since the lot number was not provided, for item# 114803, or determined during the complaint evaluation.No additional information was obtained to assist in the event identification.As of 4-may-2018, the records needed for review, to include verification of an acceptable sterilization process, have not been forwarded by zimmer-biomet.Should zimmer-biomet provide records concerning this complaint, the complaint will be re-opened and a further review shall be conducted.The root cause of this complaint was a revision surgery due to a fracture.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC ULNA 2.5X53MM RT BOND CT
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7441190
• MDR Text Key: 105844689
• Report Number: 1644408-2018-00331
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912225755
• UDI-Public: (01)00888912225755
• Combination Product (y/n): N
• PMA/PMN Number: K090473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114803
• Device Lot Number: 778490
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 114803; 114991, LOT 778490; 114803
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR