MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR 3DKNEE; EMPOWR 3D KNEETM INS, 4R 12MM, VE

Catalog Number	342-12-704
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/11/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - the revision surgery was needed for increased stability.The original 12 mm poly was exchanged for a 14 mm.
Additional Manufacturer Narrative
The reason for this revision surgery was for increased stability.The previous surgery and the revision detailed in this investigation occurred 7 months apart.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to an instability.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 device was disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhr) shows that the reported components used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports associated with the product that may have contributed to knee instability the device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of use during the previous surgery.The customer complaint history of the reported device (s) showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to a patient's knee instability.There are multiple factors which may cause joint instability that are outside the control of djo surgical are incorrect implant selection, incorrect surgical technique or patient bone deterioration.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved that may have contributed to knee instability and hence a definitive root cause cannot be determined.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: EMPOWR 3DKNEE
• Common Device Name: EMPOWR 3D KNEETM INS, 4R 12MM, VE
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6300328
• Report Number: 1644408-2017-00041
• Device Sequence Number: 1563654
• Product Code: JWH
• UDI-Device Identifier: 00888912167413
• UDI-Public: (01)00888912167413
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K143242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2017

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: 03/24/2021
• Device Catalogue Number: 342-12-704
• Device Lot Number: 178T1008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 03/29/2017
• 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