MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR 3D KNEE; EMPOWR 3D KNEETM INS, 7R 14MM, VE

Model Number	342-14-707
Health Effect - Clinical Code	Fall (1848)
Date of Event	11/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was a the patient fell and opened the wound, doctor did a poly swap.The previous surgery and the surgery detailed in this event occurred 9 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 device was disposed of at the hospital and not made available to djo surgical for examination.A review of the device history record shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There was a non-conforming material report (ncmr) ncmr#33483 associated with the main part number 342-14-707, empowr 3d kneetm ins, 7r 14mm, ve, which documents that out of 10 parts lot, all parts were rejected due to color change.All the rejected parts were reworked and accepted after proper justification.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 fall.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.Due to the short time between previous and revision surgery, it is also possible that the event may have been occurred due to lack of post-operative care, patient noncompliance with medical instructions, improper surgical technique or incorrect implant selection.There are multiple factors that may contribute to an event that are outside the control of djo surgical such as excessive range of motion, patient activities or trauma.There were no findings during this evaluation that indicate that the reported device was defective.There are no indications of a product or process issue affecting implant safety or effectiveness.
Event or Problem Description
Revision surgery - due to the patient falling and opening the wound doctor did a poly swap.

• Brand Name: EMPOWR 3D KNEE
• Common Device Name: EMPOWR 3D KNEETM INS, 7R 14MM, VE
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 9338806
• Report Number: 1644408-2019-01148
• Device Sequence Number: 11308577
• Product Code: JWH
• UDI-Device Identifier: 00888912167543
• UDI-Public: (01)00888912167543
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K143242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/13/2021
• Device Model Number: 342-14-707
• Device Catalogue Number: 342-14-707
• Device Lot Number: 141T1024
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2019
• Supplement Date Received by Manufacturer: 11/02/2019
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR