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
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Perforation of Vessels (2135); Osteolysis (2377)
Date of Event	03/25/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
D10: concomitant products: stem extension 160l x12 mm (cat# 204-32-16 / serial# (b)(6)); 3" trocar, mod.Hex 2pk (cat# 201-78-81 / serial# (b)(6)); 3" trocar, mod.Hex 2pk (cat# 201-78-81 / serial# (b)(6)); trapezoid tibial tray sz 1f/2t, 2f/2t (cat# 204-04-22 / serial# (b)(6)); three peg patella 32mm (cat# 200-02-32 / serial# (b)(6)).The reason the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and loosening or due to inclusion of the polyethylene in the packaging recall.However, the reported prosthesis wear and loosening could not be confirmed and potential contributions of user, or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.

• Brand Name: CC TIBIAL INSERT SZ 2, 15MM
• Common Device Name: 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
• Report Number: 1038671-2023-00061
• Device Sequence Number: 12112410
• Product Code: JWH
• UDI-Device Identifier: 10885862054197
• UDI-Public: 10885862054197
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

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?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11-4132 STRYKER SYS 6 90X13/21X1.19
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female