MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR PS KNEE; EMPOWR PS KNEETM TIBIAL INSERT, SIZE 11, 11MM

Model Number	343-11-711
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 possible early infection and needed a poly swap.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as infection.The actual length of in-vivo for the item listed is unknown as the original surgery date was not provided or could be established.The healthcare professional indicated that there was a significant adverse event to patient.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The revision surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.This investigation is limited in scope as only partial information was provided to djo surgical.The revised item was not returned for examination and the item and or lot number was not provided.To adequately investigate this event, the part and or lot number are necessary.In addition to the part and or lot number not being supplied, information regarding cultures identified in the infection and the severity of the infection was not supplied.The lot number reported is invalid, therefore the history of the item could not be reviewed.Customer complaint history of the reported item showed no present trends or on-going issues that are needing a review.The root cause of this complaint was infection.There were no findings during this evaluation that indicate the reported device was defective.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.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.

• Brand Name: EMPOWR PS KNEE
• Common Device Name: EMPOWR PS KNEETM TIBIAL INSERT, SIZE 11, 11MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 10726613
• Report Number: 1644408-2020-00950
• Device Sequence Number: 19300797
• Product Code: JWH
• UDI-Device Identifier: 00888912172158
• UDI-Public: (01)00888912172158
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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 Model Number: 343-11-711
• Device Catalogue Number: 343-11-711
• Device Lot Number: C0029661
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 02/10/2021
• 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: Other; Required Intervention
• Patient Age: 66 YR