MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR KNEE; EMPOWR 3D KNEETM, PRESS FIT FEMUR, 8L

Model Number	353-01-109
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint - during a 4 month follow-up with an empowr porous knee patient, the surgeon noticed that the "femus" was loose.The patient is also being worked up for an infection.The surgeon indicated the labs will be "worked up" the next day.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this complaint was due to the baseplate being positioned further posterior due to the punches not being well guided.The implant was in vivo for 4 months prior to this report.There is no information about any patient injuries, activities, accidents, or medical contraindications that may have contributed to the reported condition.A follow up conversation with the surgeon provided clarity regarding surgery date and patient gender, allowing specific part and lot number to be identified.It was later confirmed that no infection was found.The patient will continue to be monitored and is not currently scheduled for revision surgery.The x-ray was provided and small lucent lines are visible around the femur.A review of the device history record (dhr) for the empowr press fit femur revealed one non-conforming material report (ncmr) associated with the product.One piece was split to another work order per non-conforming material report (ncmr)-39983 for rework of scuff marks on the pegs.The incident femur was one of eight pieces in the lot released from manufacture on or about 23-oct-2017, and having an expiration date of 13-oct-2020.Parts were batched from raw material part, 24301108-12, polished, empowr 3d knee, press fit femur, 8l, lot #297w1001.No non-conforming material report (ncmrs) were written at receiving inspection.The device history record (dhr) evidences that all critical dimensions and specifications were met when the product was released from djo surgical.Review of complaint history shows that this is the first complaint against this part/lot number.This surgery was one of the first surgeries completed for the empowr porous system.There was no information reported that evidences a material, design, or manufacturing problem with the implants.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.The device history record (dhr) evidences that all critical dimensions and specifications were met when the product was released from djo surgical.

• Brand Name: EMPOWR KNEE
• Common Device Name: EMPOWR 3D KNEETM, PRESS FIT FEMUR, 8L
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7366390
• Report Number: 1644408-2018-00253
• Device Sequence Number: 1718782
• Product Code: MBH
• UDI-Device Identifier: 00190446230076
• UDI-Public: (01)00190446230076
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2019

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: 10/13/2023
• Device Model Number: 353-01-109
• Device Catalogue Number: 243-01-108
• Device Lot Number: 277W1000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/08/2018
• Supplement Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 03/23/2018
• Supplement Report FDA Received Date: 01/08/2019
• 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: 341-10-709, LOT 069T1033; 353-01-109, LOT 194W1001
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR