MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; SEE H10

Model Number CC TIBIAL INSERT SZ 5, 13MM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Fluid Discharge (2686); Joint Laxity (4526)

Event Date 09/21/2023

Event Type  Injury  

Event Description

It was reported that a 59 yo male patient, initial left knee implanted on (b)(6) 2011, who was revised on (b)(6) 2016, underwent a 2nd revision procedure on (b)(6) 2023, approximately 6 years 10 months post the first revision procedure.The patient had pain, recurrent and progressive effusions, and instability.The patient was revised to a 208-25-18 cc tibial insert sz 5 18mm.No device images or x-rays were provided.There were no surgical delays or device breakages reported.The patient was last known to be in stable condition following the event.No device returns anticipated for analysis due to the hospital policy.No further information.The first revision was reported under mdr 1038671-2022-01080.

Manufacturer Narrative

D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer d10: concomitants: 200-02-38 - three peg patella 38mm 4463646; 204-04-55 - trapezoid tibial tray sz 5f/5t 4375400; 204-34-04 - fluted stem extension 40l x 14 mm 4537199; 204-36-08 - stem extension 80l x16 mm 4532580; 204-65-88 - tibial augment block 1/2-sz 5 11mm rllm 2296114; 204-65-89 - tibial augment block 1/2-sz 5 11mm llrm 2817235; 208-01-05 - cc femoral sz 5 9854477; 208-07-05 - cc posterior fem augment sz 5, 5mm 2358201; 208-08-05 - cc posterior fem augment sz 5, 10mm 2781671; 208-09-05 - cc stem ext adaptor 5 degree 4286820; 400-40-14 - flex osteotome-flat, nar 4602995; tpa-18 - cement restrictor small ab0070; tpa-24 - cement restrictor large aa9698.Additional information, including the product investigation, will be submitted within 30 days of receipt.

• Brand Name: OPTETRAK
• Type of Device: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17924976
• MDR Text Key: 325572542
• Report Number: 1038671-2023-02522
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/12/2023

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: 04/15/2020
• Device Model Number: CC TIBIAL INSERT SZ 5, 13MM
• Device Catalogue Number: 208-25-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2023
• Initial Date FDA Received: 10/12/2023
• Date Device Manufactured: 04/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0019-2022
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male