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

Catalog Number 114803

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 05/15/2020

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was reported due to loosening.The previous surgery and the surgery detailed in this event occurred 1.6 years apart.The healthcare professional indicated there was no delay in surgery and another suitable device was not available for use.The revision surgery was completed as intended.The devices were disposed of at hospital and not made available to djo surgical for examination.A search of djo records produced no results.Because of the acquisition by djo surgical, an extended search of zimmer biomet records cannot be conducted.Any records before the acquisition date, that have not been forwarded, will not be made available.Customer complaint history of the reported devices 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 loosening.The findings did not lead to a firm conclusion since the needed records were not made available at the time of this investigation.If more information is received later, the complaint will be updated.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 - right total elbow ulna revision due to loosening.

• 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
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx
• Manufacturer Contact: teffany hutto ; 9800 metric blvd; austin, tx
• MDR Report Key: 10148243
• MDR Text Key: 195088544
• Report Number: 1644408-2020-00452
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090473
• 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: 06/11/2020

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: 04/28/2021
• Device Catalogue Number: 114803
• Device Lot Number: 921510
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 06/12/2020
• 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: 50 YR