MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC ULNA 3X115MM LT W BRNG C

Catalog Number 114816

Device Problems Break (1069); Naturally Worn (2988); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 05/12/2016

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was due to pain.The previous surgery and the surgery detailed in this event occurred 5.2 years apart.This evaluation is limited in scope as the item associated with this investigation was not returned to djo surgical - austin for examination.The surgery was completed as intended and without incident.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.A review of the device history record(s) show that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no nonconforming material reports associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to pain.There were no findings during this evaluation that indicate that the reported device was defective.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.

Event Description

Revision surgery - patient underwent left total elbow arthroplasty.Patient underwent a revision procedure in due to pain, decreased function and poly wear.During the revision surgery; the surgeon found the humeral condyle kit and bearings to be damaged, and severe catastrophic wear of the ulnar component.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC ULNA 3X115MM LT W BRNG 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: 9056640
• MDR Text Key: 161275442
• Report Number: 1644408-2019-00857
• 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
• Report Date: 09/13/2019

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 Expiration Date: 05/31/2015
• Device Catalogue Number: 114816
• Device Lot Number: 265200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2010
• 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: 73 YR