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

Model Number 130-03-735

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 12/17/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision surgery - due to switched from empowr to epic.

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.

Manufacturer Narrative

D10 adding concomitant part 600-15-000.

• Brand Name: EMPOWR POROUS KNEE
• Type of Device: 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
• MDR Text Key: 175195030
• Report Number: 1644408-2020-00015
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00888912108553
• UDI-Public: (01)00888912108553
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171991
• 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,Followup,Followup
• Report Date: 08/04/2022

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: 130-03-735
• Device Catalogue Number: 243-02-107
• Device Lot Number: 286W1021
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 01/15/2020
• Supplement Dates Manufacturer Received: 01/30/2020; 01/30/2020
• Supplement Dates FDA Received: 02/28/2020; 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2019
• 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
• Treatment: 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
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male