MAUDE Adverse Event Report: ENCORE MEDICAL L.P EMPOWR 3D KNEE; DJO EMPOWR KNEETM, FIN BP MINUS, NP 6R

Model Number 351-04-106

Device Problems Therapeutic or Diagnostic Output Failure (3023); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision surgery - revised a loose size 6 right tibia baseplate that loosened in the cement mantle.Believed to be a cement mantle failure and not a component failure.Done roughly 2 months ago.Put in a universal baseplate with stem and new 3d poly.

Manufacturer Narrative

The reason for this revision surgery was reported as loosening.The previous surgery and the surgery detailed in this event occurred 2 months and 2 weeks apart.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 device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.The devices were verified to have gone through an acceptable sterilization process and 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 was reported as loosening from cement mantle failure.There were no findings during this evaluation that indicate the reported devices were defective.No other 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 also contribute to an event that are outside the control of djo surgical such as poor bone density, patient bone deterioration, inadequate soft tissue support, patient activities or trauma.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: EMPOWR 3D KNEE
• Type of Device: DJO EMPOWR KNEETM, FIN BP MINUS, NP 6R
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin,tx 78758-5445
• MDR Report Key: 10884820
• MDR Text Key: 217670212
• Report Number: 1644408-2020-01070
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00888912168137
• UDI-Public: (01)00888912168137
• Combination Product (y/n): N
• PMA/PMN Number: K143242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

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 Model Number: 351-04-106
• Device Catalogue Number: 351-04-106
• Device Lot Number: 033T1092
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/23/2020
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 342-10-706 LOT 076T1082; 342-10-706 LOT 076T1082
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR