MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR CR KNEE; EMPOWR CR KNEETM TIBIAL INSERT, LEFT, SIZE 8, 12MM

Model Number	344-12-708
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was reported as dislocation.The previous surgery and the surgery detailed in this event occurred 1 year apart.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 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 - austin for review.The revised item was not returned for examination and the lot number was not provided.To adequately investigate this event, the lot number is necessary.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 dislocation.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.
Event or Problem Description
Revision surgery - patient needed a thicker insert due to laxity in the knee.

• Brand Name: EMPOWR CR KNEE
• Common Device Name: EMPOWR CR KNEETM TIBIAL INSERT, LEFT, SIZE 8, 12MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445,
• MDR Report Key: 10482765
• Report Number: 1644408-2020-00706
• Device Sequence Number: 2795624
• Product Code: JWH
• UDI-Device Identifier: 00190446215356
• UDI-Public: (01)00190446215356
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2020

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 Model Number: 344-12-708
• Device Catalogue Number: 344-12-708
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 09/02/2020
• 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: Other; Required Intervention
• Patient Age: 66 YR