MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC CONDYLE KIT WITH HEXALOBULA

Catalog Number 114700

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2019

Event Type  Injury  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

Revision surgery - due to unaware of the reason for revision after multiple follow ups with the customer.

Manufacturer Narrative

The reason for this revision surgery was not reported, it is unknown.The actual length of in-vivo for the items listed is unknown since the revision surgery date was not provided or could be 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 devices were disposed of at hospital and not made available to djo surgical for examination.A review of the implant device history records (dhr) shows that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There were no nonconforming material reports (ncmr) associated with the products that may have contributed to an event.The devices were within its expiration date at the time of the previous surgery.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 is unknown, since the reason for the revision was not reported.There were no findings during this evaluation that indicate the reported devices were 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 the event.There are multiple factors that may contribute to an event that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC CONDYLE KIT WITH HEXALOBULA
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445, TX 78758 5445
• MDR Report Key: 9452367
• MDR Text Key: 170445852
• Report Number: 1644408-2019-01237
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K051975
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

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 Catalogue Number: 114700
• Device Lot Number: 711370
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 12/11/2019
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 114993, LOT 674080; 114993, LOT 992810
• Patient Outcome(s): Required Intervention