MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. EMPOWR KNEE; DJO EMPOWR KNEETM, FIN BP, NP 7R

Catalog Number	351-02-107
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/09/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Second revision surgery - due to the patient being revised for instability and collateral laxity; the empowr knee was removed and converted to an exprt revision.
Additional Manufacturer Narrative
The reason for this revision surgery was instability and collateral laxity.The previous surgery and the revision detailed in this investigation occurred over 5.8 months apart.There are no reported pre-existing patient health conditions.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 device history records (dhrs) revealed no discrepancies or issues with the manufacturing of this part.All critical dimensions and specifications in effect at the time the part was manufactured were met.There were no ncmrs associated with the components that may have contributed to reported event.The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review.This event is deemed to be non-product related.The root cause for the event was not reported.No other information was submitted with the complaint regarding any activities the patient was involved in that may have contributed to the reported event.There are multiple factors that may contribute to an event; these are outside of the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: EMPOWR KNEE
• Common Device Name: DJO EMPOWR KNEETM, FIN BP, NP 7R
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• MDR Report Key: 6231197
• Report Number: 1644408-2016-01058
• Device Sequence Number: 10977175
• Product Code: JWH
• UDI-Device Identifier: 00888912167949
• UDI-Public: (01)00888912167949
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2017

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: 02/26/2022
• Device Catalogue Number: 351-02-107
• Device Lot Number: 993R1020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2017
• Supplement Report FDA Received Date: 02/17/2017
• 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: 241-02-107,LOT 951R1035; 342-10-707,LOT 077T1013
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR