MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR KNEE SYSTEM; EMPOWR 3D KNEETM, PRESS FIT FEMUR, 7L

Model Number 353-03-107

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 07/31/2019

Event Type  Injury  

Event Description

Revision surgery due to loose tibial and femoral components.

Manufacturer Narrative

Corrected data: see d1, d2,d4, d11.Narrative/data: the reason for this revision surgery was due to loose tibial and femoral components.The previous surgery and the surgery detailed in this event occurred 21 days apart.The healthcare professional indicated there was no significant adverse event to the patient.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 device history record 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 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.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.

• Brand Name: EMPOWR KNEE SYSTEM
• Type of Device: EMPOWR 3D KNEETM, PRESS FIT FEMUR, 7L
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8939795
• MDR Text Key: 156820361
• Report Number: 1644408-2019-00885
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00190446230250
• UDI-Public: (01)00190446230250
• Combination Product (y/n): N
• PMA/PMN Number: K171991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 353-03-107
• Device Catalogue Number: 243-01-107
• Device Lot Number: 276W1018
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 243-01-107. LOT 276W1018; 341-12-707. LOT 111T1049; 341-12-707. LOT 111T1049; 353-03-107. LOT 212W1012
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR