MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 2, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number CC TIBIAL INSERT SZ 2, 15MM

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 03/25/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: stem extension 160l x12 mm (cat# 204-32-16 / serial# (b)(4)).3" trocar, mod.Hex 2pk (cat# 201-78-81 / serial# (b)(4)).3" trocar, mod.Hex 2pk (cat# 201-78-81 / serial# (b)(4)).Trapezoid tibial tray sz 1f/2t, 2f/2t (cat# 204-04-22 / serial# (b)(4)).Three peg patella 32mm (cat# 200-02-32 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported by the legal team, in 2006, patient sought treatment for knee pain.At the recommendation of the orthopedic surgeon, she underwent knee replacement surgery on her right knee with an optetrak knee replacement system, including the defective insert and defective tibial tray.In 2008, less than two years after her knee replacement surgery, patient developed loosening of the device and pain in her right knee.On (b)(6) 2008, patient underwent a surgical revision of her right knee due to "failed right knee with a loose tibial component".At the time of surgery, it was discovered that patient right knee was also infected and, therefore, the optetrak knee replacement system and its components were removed while patient underwent treatment for the infection.Patient continued treatment for the infection until (b)(6) 2009, when another optetrak knee replacement system was implanted in her right knee, along with another defective insert.At that time, unbeknownst to patient, patient continued to have pain and instability in connection with her optetrak knee replacement system and, in (b)(6) 2012, it was determined that the device had again loosened and failed, and that, therefore, she was required to undergo another revision.On (b)(6) 2012, surgery was once again performed on patient's right knee.At this re-revision, another defective insert was implanted in patient's knee.Patient continued to have difficulty with her right knee, and, in march 2021, she switched her care to different hospital.On (b)(6) 2021, patient underwent another revision due to loosening and bone loss related to the defective insert.As a result of this revision surgery, patient's popliteal artery was severed, and patient continues to suffer from medical complications and risks.

• Brand Name: CC TIBIAL INSERT SZ 2, 15MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16225409
• MDR Text Key: 307919453
• Report Number: 1038671-2023-00061
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862054197
• UDI-Public: 10885862054197
• 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: Other,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2014
• Device Model Number: CC TIBIAL INSERT SZ 2, 15MM
• Device Catalogue Number: 208-22-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2009
• 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: 11-4132 STRYKER SYS 6 90X13/21X1.19
• Patient Outcome(s): Required Intervention
• Patient Sex: Female