MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR 3D KNEE; EMPOWR 3D KNEETM INS, 8L 14MM, VE

Model Number	341-14-708
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was due to loosening.The previous surgery and the surgery detailed in this event occurred 1 year and 7 months apart.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed successfully.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) shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material report (ncmr) 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 loosening.There were no findings during this evaluation that indicate that the reported device was defective.The surgeon performed this procedure to remedy the patient's condition.No further action is deemed necessary.There are many factors that may contribute to the event that are outside the control of djo surgical such as poor bone density, patient bone deterioration, inadequate soft tissue support, excessive range of motion, patient activities or trauma.
Event or Problem Description
Revision surgery - due to the patient still complaining of laxity after prior revision.

• Brand Name: EMPOWR 3D KNEE
• Common Device Name: EMPOWR 3D KNEETM INS, 8L 14MM, VE
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 9540491
• Report Number: 1644408-2020-00001
• Device Sequence Number: 2335177
• Product Code: JWH
• UDI-Device Identifier: 00888912167055
• UDI-Public: (01)00888912167055
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K143242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/27/2022
• Device Model Number: 341-14-708
• Device Catalogue Number: 341-14-708
• Device Lot Number: 132T1028
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 54 YR