MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3D KNEE SYSTEM; DJO EMPOWR KNEETM, FIN BP, NP, 5L

Model Number	344-11-705
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery- revised tibia and insert due to medical post operative knee pain.
Additional Manufacturer Narrative
The reason for this revision surgery was due to pain.The actual length of in-vivo for the item listed is unknown as the original surgery date was not provided or could be established.Given the limited information, an extensive search for an invoice of the previous surgery produced no results.The healthcare professional indicated there was a significant adverse event to the patient.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 show that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no nonconforming material reports associated with the product that may have contributed to the reported event.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 pain.There were no findings during this investigation that indicate that the reported device was 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 of the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: 3D KNEE SYSTEM
• Common Device Name: DJO EMPOWR KNEETM, FIN BP, NP, 5L
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin texas 78758; austin TX 78758 5445
• MDR Report Key: 8875580
• Report Number: 1644408-2019-00750
• Device Sequence Number: 2755336
• Product Code: JWH
• UDI-Device Identifier: 00190446215226
• UDI-Public: (01)00190446215226
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2019

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: 09/18/2024
• Device Model Number: 344-11-705
• Device Catalogue Number: 351-01-105
• Device Lot Number: 981R1107
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 344-11-705. LOT 601V1001.; 351-01-105 LOT 981R1107.; 351-01-105 LOT 981R1107
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 68 YR