MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR PS KNEE; EMPOWR PS KNEETM TIBIAL INSERT, SIZE 5 BRIDGE UP, 14MM

Model Number	343-14-755
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was reported as an infection.The previous surgery and the surgery detailed in this event occurred 3 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.This event was the second stage of a two stage process to alleviate a patient previous infection (the previous infection was the removal of non djo components).Upon determination that the infection is under control and the tissue is normalized, the construct is removed and new components are implanted.There was no new information regarding cultures identified in the infection, severity of the infection or any patient activities, accidents, or medical contraindications that may have contributed to the previous infection.This event is not the result of a product deficiency, failure or issue.The surgery was completed as intended and without incident.No further action is deemed necessary.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 - patient had an antibiotic spacer put in about a month ago for infection, which consisted of a ps femur and ps insert.Spacer was removed and replaced.

• Brand Name: EMPOWR PS KNEE
• Common Device Name: EMPOWR PS KNEETM TIBIAL INSERT, SIZE 5 BRIDGE UP, 14MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 12365535
• Report Number: 1644408-2021-00882
• Device Sequence Number: 14437906
• Product Code: JWH
• UDI-Device Identifier: 00888912172448
• UDI-Public: (01)00888912172448
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K160342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2021

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: 06/13/2021
• Device Model Number: 343-14-755
• Device Catalogue Number: 343-14-755
• Device Lot Number: 251U1006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 08/25/2021
• 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: 242-01-106 LOT 859T1252
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR