MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EPIK UNI KNEE; INSERT, ONLAY TIBIAL, EPIK, SIZE42X9

Model Number 340-42-009

Device Problems Naturally Worn (2988); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 10/24/2018

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was reported as excessive wear.The previous surgery and the surgery detailed in this event occurred 4 years and 11 months 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 records (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 scratches/scuffs, signs of usual wear.It also exhibits several series of parallel lines, small scratches indicative of metal wear from repeated articulating motion of the joint.The baseplate has returned with significant bone/cement still attached, indicating good fixation to the bone.A corner of the baseplate has developed some metal-metal wear, a sign that the femur was in contact with a region of the baseplate instead of only contacting the poly insert.The corner of the baseplate with metal-metal wear is the same corner where the poly insert has developed most of its wear.The poly insert is still affixed to the baseplate.The poly insert has returned with significant delamination.There is also extreme wear of the articulating surface, leaving behind a jagged surface with material missing entirely in the corner where the baseplate shows metal-metal wear.

Event Description

Revision surgery - revision for excessive wear.

• Brand Name: EPIK UNI KNEE
• Type of Device: INSERT, ONLAY TIBIAL, EPIK, SIZE42X9
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer Contact: teffany hutto ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 9764216
• MDR Text Key: 181334621
• Report Number: 1644408-2020-00141
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00888912116084
• UDI-Public: (01)00888912116084
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: 340-42-009
• Device Catalogue Number: 340-42-009
• Device Lot Number: 59600277
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR