MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EPIK UNI KNEE; INSERT, ONLAY TIBIAL, EPIK, SIZE35X10

Model Number	340-35-010
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was reported as excessive wear.The previous surgery and the surgery detailed in this event occurred 5 years apart.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 devices were returned to manufacturer and examined by registered medical assistant (rma) at djo surgical.A review of the device history record (dhr) shows that the poly insert met design and manufacturing requirements when released for use.There were no non-conforming material reports (ncmr) associated with the production of this lot that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of implantation.The vendor's certificate of conformance was reviewed, and it confirms that the poly insert's material met specifications per ms0002, revision d.No complaints have been filed against any other parts from this lot.Djo is aware of 16 other revisions surgeries due to worn poly inserts in the history of the epik system.There is no indication that there are any present trends or on-going issues that need review.A review of survivorship for epik knees, including a study of all wear-related complaints, has been conducted.It shows that djo's epik systems have a rate of survivorship (97.7%) that is higher than the industry standard, emphasizing that there is no larger manufacturing or design problem with epik parts.This analysis is attached to this complaint.The root cause of this complaint was a revision surgery due to excessive wear.There are several factors that may have contributed to the need to revise this epik system.The poly insert shows evidence of delamination, which is the product of oxidation, a factor known to accelerate wear.Additionally, point loading is common in unicondylar knee systems, meaning more load is focused in a single location of the poly insert.Furthermore, the location of this insert's wear is evidence of an off-center loading point, which is likely an indicator of surgical malalignment between the femur and the baseplate, which can also accelerate wear.Other patient contraindications that could have contributed to excessive poly wear include obesity, abnormal gait, and degenerative bone disease.There are no indications of a product or process issue affecting implant safety or effectiveness.Rma examination: the femur has returned with significant bone/cement still attached, indicating good fixation to the bone.The articulating surface has several minor scuffs, signs of usual wear.The baseplate and poly insert have returned for examination, still stuck together.The baseplate has significant bone/cement still attached, indicating good fixation to the bone.The baseplate is otherwise undamaged.The poly insert has significant delamination and shows signs of extreme wear covering one half of the articulating surface, the half nearer the straight edge and farther from the curved edge.The insert's wear has left behind a jagged surface with most material missing in one corner.
Event or Problem Description
Revision surgery - revision for excessive wear.

• Brand Name: EPIK UNI KNEE
• Common Device Name: INSERT, ONLAY TIBIAL, EPIK, SIZE35X10
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 9764209
• Report Number: 1644408-2020-00143
• Device Sequence Number: 2650035
• Product Code: HRY
• UDI-Device Identifier: 00888912115902
• UDI-Public: (01)00888912115902
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K020741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2020

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 Expiration Date: 10/31/2016
• Device Model Number: 340-35-010
• Device Catalogue Number: 340-35-010
• Device Lot Number: 323B1001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/27/2020
• 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: Required Intervention