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

Model Number	130-03-735
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - due to switched from empowr to epic.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was reported as switching of empower knee to epic knee.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) shows that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements and showed no non-conforming material reports (ncmr) associated with the main contributor component listed in the complaint.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 a revision surgery due to switched to empowr knee to epic knee.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 to the event.There are multiple factors that may contribute to an event that are outside the control of djo surgical such as poor bone density, patient bone deterioration, inadequate soft tissue support, prolonged overhead activities, patient activities or trauma.There are no indications of a product or process issue affecting implant safety or effectiveness.
Additional Manufacturer Narrative
D10 adding concomitant part 600-15-000.

• Brand Name: EMPOWR POROUS KNEE
• Common Device Name: EMPOWR 3D KNEETM, PRESS FIT FEMUR, 7R
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445 TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445 TX 78758 5445
• Manufacturer Contact: teffany hutto ; 9800 metric blvd; austin, tx 78758-5445, TX 78758-5445
• MDR Report Key: 9593448
• Report Number: 1644408-2020-00015
• Device Sequence Number: 18961942
• Product Code: MBH
• UDI-Device Identifier: 00888912108553
• UDI-Public: (01)00888912108553
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K171991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2022
• 2 Devices were Involved in the Event: 1 2

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: 03/06/2025
• Device Model Number: 130-03-735
• Device Catalogue Number: 243-02-107
• Device Lot Number: 286W1021
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 01/30/2020; 01/30/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 02/28/2020; 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 130-03-735 LOT 156N1506; 243-02-107. LOT 286W1021; 342-16-707 LOT 161T1021; 342-16-707. LOT 161T1021; 353-04-107 LOT 222W1010; 353-04-107. LOT 222W1010; 600-15-000 COBALT HV BONE CEMENT 40GM; 243-02-107. LOT 286W1021; 342-16-707. LOT 161T1021; 353-04-107. LOT 222W1010
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male