MAUDE Adverse Event Report: ENCORE MEDICAL L.P EMPOWR PS KNEE; EMPOWR PS KNEETM FEMUR, NONPOROUS, 5R

Model Number 242-02-105

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/27/2022

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was reported as fracture.The previous surgery and the surgery detailed in this event occurred 36 days 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 was a nonconformance associated with the main part #242-02-105, empowr ps kneetm femur, nonporous, 5r which documents that out of 20 parts lot 1 part was rejected and scrapped during inspection.All other items in the lot were met with fit, form and function requirements.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 fracture.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.Due to short time between previous and revision surgery, it is possible that the event may have occurred due to lack of post-operative care, patient noncompliance with medical instructions, incorrect implant selection, patient activities or trauma.There are multiple factors that may also contribute to an event that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.

Event Description

Revision surgery - femur sustained a stress fracture and caused knee to fall into varus.

• Brand Name: EMPOWR PS KNEE
• Type of Device: EMPOWR PS KNEETM FEMUR, NONPOROUS, 5R
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758 5445
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 16077581
• MDR Text Key: 306421829
• Report Number: 1644408-2022-01794
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160342
• 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
• Report Date: 12/30/2022

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 Expiration Date: 05/12/2023
• Device Model Number: 242-02-105
• Device Catalogue Number: 242-02-105
• Device Lot Number: 868T1084
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/27/2022
• Initial Date FDA Received: 12/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2017
• 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: 346-12-705 LOT 435V1026
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female