MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR 3D KNEE; EMPOWR 3D KNEETM INS, 9L 16MM, VE

Model Number 341-16-709

Device Problems Unstable (1667); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 04/16/2019

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was due to instability.The previous surgery and the revision detailed in this investigation occurred 19 days apart.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.Initial or prolonged hospitalization was required.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 implant device history records (dhr) shows that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the event.The device was within its expiration date at the time of use during the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to instability.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the patient's event.There are multiple factors that may contribute to the event that are outside the control of djo surgical such as: poor bone density, inadequate soft tissue support, patient bone deterioration, degenerative bone disease, patient activities or trauma.Due to the short time between the previous and revision surgery, the event may have possibly occurred due to improper surgical technique, patient non-compliance with medical instructions.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

Event Description

Revision surgery - due to instability.

• Brand Name: EMPOWR 3D KNEE
• Type of Device: EMPOWR 3D KNEETM INS, 9L 16MM, VE
• 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: 8608373
• MDR Text Key: 145009925
• Report Number: 1644408-2019-00428
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00888912167161
• UDI-Public: (01)00888912167161
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143242
• 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: 05/14/2019

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: 01/17/2021
• Device Model Number: 341-16-709
• Device Catalogue Number: 341-16-709
• Device Lot Number: 153T1005
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/16/2019
• Initial Date FDA Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 70 YR