MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR 3DKNEE; DJO EMPOWR KNEETM, FIN BP, NP 4R

Catalog Number	351-02-104
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/04/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the anatomical alignment being off.A gap from the tibial plate to the femur is causing anterior dislocation.
Additional Manufacturer Narrative
The reason for this revision surgery was anterior dislocation.The in-vivo length of patient service for the implant was 4.6 months.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 (b)(4) 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.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 as non-product related.The root cause for this event was the anatomical alignment of the gap from tibial plate to femur caused anterior dislocation.The scope of this investigation is limited without having the parts available to (b)(4) for evaluation.Other conditions relating to this event could not be determined with confidence.Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.
Additional Manufacturer Narrative
Corrected data: correcting the follow-up #1 manufacturer narrative; quality analyst made changes.Manufacture narrative: the reason for this revision surgery was the mis-alignment of the femur (size 2) and tibial baseplate (size 4) led to a patient dislocation.The in-vivo length of patient service for the implant was 4.6 months.The complaint reported no issues of any other patient injuries, activities, accidents or manufacturing contraindications that may have been contributory to this surgery.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, design criteria and specifications in effect at the time the part was manufactured were met.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 as non-product related.The root cause for this event was the mis-alignment of the femur (size 2) and tibial baseplate (size 4) led to a patient dislocation.Review of the surgical history indicates that the surgeon implanted a size 2 femoral component and size 4 tibial components.This combination of sizes is not recommended in the surgical technique.The scope of this investigation is limited without having the parts available to djo surgical for evaluation.Other conditions relating to this event could not be determined with confidence.The revision surgery was successfully completed and without incident.Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: EMPOWR 3DKNEE
• Common Device Name: DJO EMPOWR KNEETM, FIN BP, NP 4R
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6280760
• Report Number: 1644408-2017-00039
• Device Sequence Number: 11031605
• Product Code: JWH
• UDI-Device Identifier: 00888912167918
• UDI-Public: (01)00888912167918
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,Followup
• Report Date (Section B): 05/24/2017

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: 08/31/2021
• Device Catalogue Number: 351-02-104
• Device Lot Number: 990R1024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/04/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/26/2017
• Supplement Report FDA Received Date: 03/10/2017; 05/24/2017
• 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: 70 YR