MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EPIK UNI KNEE; INSERT, ONLAY TIBIAL, EPIK, SIZE35X9

Model Number 340-35-009

Device Problems Use of Device Problem (1670); Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 09/19/2017

Event Type  Injury  

Event Description

Primary surgery - due to the surgeon complaining that both tibial inserts failed to lock properly into the baseplate.He did not know which implant was the problem, the baseplate or the insert.He said the trial insert also had a tough time fully seating.

Manufacturer Narrative

The reason for this complaint was due to a tibial insert failing to lock properly into the baseplate.The surgeon did not know which implant was the problem, the baseplate or the insert.The surgeon said the trial insert also had a tough time fully seating.There were no risk or adverse events indicated, and surgery was completed as intended.Additional information was received on 12-oct-2017.Customer service called the sale representative regarding the quantity issue on the product complaint and the delivery ticket.The representative is actually returning 1 insert and no baseplate.He said the surgeon tried the first insert and did not like the fit and then used a 2nd insert and got it in, he still did not like the fit but he left it.If there was another insert available the representative said that they probably would have swapped it out.The first insert was returned on returned materials authorization (rma) e925332 and examined.One of the locking feet is heavily damaged, probably from removal after insertion in the baseplate during surgery.The remaining locking foot is undamaged, indicating that it never achieved assembly with the baseplate.Witness marks, unevenly distributed along the radius of the lateral side of the insert as well as the corner of the medial edge, indicates that the poly component was rotated out of alignment with the baseplate at the time of impaction.A review of the device history record (dhr) for the onlay tibia insert, epik revealed no non-conforming material reports (ncmr's) associated with the product.The device history record (dhr) evidences that all critical dimensions and specifications were met when the product was released from djo surgical.In addition, 2 pieces from this lot have been consumed in other surgeries review of complaint history shows that this is the first complaint against this part/lot number.In the epik family there is record of 3 other occurrences of the insert failing to snap into the baseplate between 2006 and 2016: 1st product complaint: insert would not snap in after 20 minutes.New one snapped in right away.; 2nd product complaint: epik insert would not lock properly into tibial baseplate.; 3rd product complaint: during procedure the surgeon went to hammer in, would not fit correctly.Checked size, and different implant of same size fit fine.Noticed that the poly was not correct on one side.The root cause identified as the reason for the complaint is that the insert was misaligned with the baseplate at the time of impaction.There was no information reported that evidences a material, design, or manufacturing problem with the products.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: EPIK UNI KNEE
• Type of Device: INSERT, ONLAY TIBIAL, EPIK, SIZE35X9
• 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: 6959362
• MDR Text Key: 89645341
• Report Number: 1644408-2017-00894
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00888912115889
• UDI-Public: (01)00888912115889
• 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: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2021
• Device Model Number: 340-35-009
• Device Catalogue Number: 340-35-009
• Device Lot Number: 322B1016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2016
• 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): Other
• Patient Age: 77 YR