MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. EPIK KNEE; INSERT, ONLAY TIBIAL, EPIK, SIZE40X9

Catalog Number 340-40-009

Device Problem Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 03/10/2016

Event Type  Injury  

Event Description

Primary surgery - the insert would not snap in after 20 minutes; new own snapped in right away.

Manufacturer Narrative

This complaint was reporting an implant failure during primary knee surgery.The healthcare professional indicated there was a 20 min delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.There are no risks or adverse conditions indicated.The original epik tibial insert was returned to (b)(4) for evaluation.A review of the device history records (dhr) showed no non-conforming material reports associated with the main contributor component listed in the complaint.Out of the 10-piece lot, the first piece was rejected on the router for an incorrect chamfer found at the condyle machining operation (op40).Since this chamfer is on the condyle side of the part, this discrepancy would not affect the ability to engage the snap features in the tibial baseplate.The condition with the chamfer was corrected and the remaining 9 pieces of the lot continued processing with no discrepancies.The lot was released from manufacture on december 10, 2015.The expiration date is listed on the product label as november 23, 2020.The dhr evidences that all critical dimensions and specifications were met when the lot was released from (b)(4).A review of the product complaint report history shows there are 6 prior complaints against the part number 340-40-009 epik tibial insert.This is the first complaint for the incident lot number, 328b1016.All prior complaints were for revision surgeries due to either infection, pain, or both.None involved difficulty with inserting the tibial insert into the epik baseplate.There are numerous scratch marks and gouges, presumably from the surgeon's attempts to snap the tibial insert into the epik baseplate during the 20 minute surgical delay.The two snap features on opposite ends of the part have been displaced slightly inward toward the center of the part, causing the 1.370 +.004/-.000 dimension to be slightly undersized at 1.362".For the same reason, the.070 ±.005 slot width is also undersized, measuring between.057" and.063".This deformation of the snap features is also likely due to the surgeon's unsuccessful attempts to snap the tibial insert into the epik baseplate.The part was additionally inspected under 10x magnification with fiber optic lighting, which revealed deformation of the backside datum a surface in certain key areas.On approximately half of the r.743 arc length, as well as on the opposite corner near datum b, there is evidence that the tibial insert was impacted while sitting up on the wall of the epik baseplate.The tibial insert appears to have been rotated by approximately 5 degrees relative to the baseplate when it was impacted.The impressions of the baseplate wall are clearly visible on the datum a surface of the tibial insert.The impressions have also caused the adjacent edges of the tibial insert to mushroom outward beyond the allowed profile tolerance.The most likely scenario is that the returned tibial insert was misaligned during initial placement and impaction.This deformed the part, making it too large to fit the epik baseplate on subsequent attempts, even when correctly aligned.There was no information reported that evidences a material, design, or manufacturing problem with the product.Based on the visual evidence including witness marks on the product, along with dimensional measurements, the most likely root cause of the failure is that the epik tibial insert was slightly rotated and sitting up on the walls of the epik baseplate when it was initially impacted.This deformed the uhmwpe material, causing adjacent edges to mushroom beyond the allowable profile tolerance.The product was then oversized in the deformed areas, and would not seat properly on subsequent attempts.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: EPIK KNEE
• Type of Device: INSERT, ONLAY TIBIAL, EPIK, SIZE40X9
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445 ; 5128346255
• MDR Report Key: 5548175
• MDR Text Key: 41903109
• Report Number: 1644408-2016-00172
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00888912116022
• UDI-Public: (01)00888912116022
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2016

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: 11/23/2020
• Device Catalogue Number: 340-40-009
• Device Lot Number: 328B1016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 04/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2015
• 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