MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	CC TIBIAL INSERT SZ 4, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: 200-02-38 - three peg patella 38mm sn: (b)(4), 204-04-45 - trapezoid tibial tray sz 4f/5t sn: (b)(4), 204-34-04 - fluted stem extension 40l x 14 mm sn: (b)(4), 204-36-12 - stem extension w/slot 120l x16 mm sn: (b)(4), 208-01-04 - cc femoral sz 4 sn: (b)(4), 208-09-05 - cc stem ext adaptor 5 degree sn: (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a male patient, who had logic cc implanted in their right knee on (b)(6) 2008, was revised on (b)(6) 2022, approximately 14 years 1 month post the initial implant procedure due to excessive wear to the implants.Revision to logic cc system went extremely well.The patient was last known to be in stable condition following the event.The device is available for return.
Additional Manufacturer Narrative
H6: the revision was likely the result of prosthesis fracture possibly due to unsupported loading of the tibial insert on the rim of the tibial tray.The posterior foot may not have been properly engaged with the tray at the time of implantation.Damage of the posterior foot and subsequent movement of the tibial insert within the tray or backside wear and/or damage of the locking mushroom of the tibial insert may have led to rotational movement of the tibial insert within the tray and subsequent disengagement between the posterior foot of the tibial insert and locking undercut on the rim of the tibial tray.The contributions of each to the sequence of events cannot be determined due to the extent of damage on the returned device.A contributing factor to the tibial insert fracture may have been oxidative embrittlement as a result of being packaged in a non-conforming vacuum bag for more than five years.
Additional Manufacturer Narrative
H10.Additional/updated informaiton-b5, d9, h7.H9.Z-0019-2022 h11.Correction- d4 serial number (b)(6), expiration date 13-nov-2011.D6a implanted date- (b)(6) 2014.D10.Concomitants: 200-01-05 - cemented cr femoral sz 5, 2808928; 200-02-41 - three peg patella 41mm, 2806561; 204-04-55 - trapezoid tibial tray sz 5f/5t, 2849621; 204-32-01 - fluted stem extension 11l x 12 mm, 2784668; 204-70-00 - tibial stem ext.Screw, 2879665; h6.Manufactured date 15-nov-2006.
Event or Problem Description
Revised on (b)(6) 2014, second revision on (b)(6) 2022, device was implanted for 8 years, 6 months.70 year old patient.Revision operative report of (b)(6) 2022.Diagnosis: failed right total knee arthroplasty secondary to polyethylene breakage and loosening.Patient tolerated the procedure well.No other information is available.

• Brand Name: CC TIBIAL INSERT SZ 4, 9MM
• 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 ; 3523771140
• MDR Report Key: 15413174
• Report Number: 1038671-2022-01100
• Device Sequence Number: 15203338
• Product Code: JWH
• UDI-Device Identifier: 10885862054326
• UDI-Public: 10885862054326
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/13/2011
• Device Model Number: CC TIBIAL INSERT SZ 4, 9MM
• Device Catalogue Number: 208-24-09
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2022
• Supplement Date Received by Manufacturer: 06/21/2023; 12/21/2023
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 06/22/2023; 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2006
• 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: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male