MAUDE Adverse Event Report: ENCORE MEDICAL L. P. EMPOWR PS KNEE SYSTEM; EMPOWR PS KNEETM TIBIAL INSERT, SIZE 10, 12MM

Model Number	343-12-710
Health Effect - Clinical Codes	Pain (1994); Scarring (2061)
Date of Event	06/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was due to persistent patellofemoral 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.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The healthcare professional indicated there was no delay in surgery and another suitable device was available.The revision surgery was completed as intended and without incident.The device was disposed of at the hospital and not made available to djo surgical for examination.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Revision surgery - due to patient having persistent patellofemoral pain, the patella was previously unresurfaced (native).The insert was explanted in order to gain room for removal of scar tissue.The patella was resurfaced.

• Brand Name: EMPOWR PS KNEE SYSTEM
• Common Device Name: EMPOWR PS KNEETM TIBIAL INSERT, SIZE 10, 12MM
• Manufacturer (Section D): ENCORE MEDICAL L. P.; 9800 metric blvd; austin, tx
• MDR Report Key: 10289972
• Report Number: 1644408-2020-00646
• Device Sequence Number: 13700946
• Product Code: JWH
• UDI-Device Identifier: 00888912172264
• UDI-Public: (01)00888912172264
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2020

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: No Information
• Device Model Number: 343-12-710
• Device Catalogue Number: 343-12-710
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 07/17/2020
• 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: 73 YR