MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 3, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	CC TIBIAL INSERT SZ 3, 13MM
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.Concomitant medical products cemented trapezoid tray (cat# 204-04-34 / serial# (b)(4).Fem.Stem ext.Adapter 5 (cat# 208-09-05 / serial# (b)(4).Three peg patella, 38mm (cat# 200-02-38 / serial# (b)(4).Cck tibial insert size 3, 13mm (cat# 208-23-13 / serial# (b)(4).3'' trocar, mod.Hex (cat# 201-78-81 / serial# (b)(4).Holding pin mini sharp point (cat# 201-78-15 / serial# (b)(4).3'' drill bit (cat# 201-78-89 / cat# (b)(4).3'' trocar, mod.Hex (cat# 201-78-81 / serial# (b)(4).Holding pin headless 3 (cat# 201-46-10 / serial# (b)(4).Post.Femoral augment sz 3, 5 mm (cat# 208-07-03 / serial# (b)(4).Distal femoral augment sz 3, 10 mm (cat# 208-06-03 / serial# (b)(4).Stem extension 80 x 18 mm (cat# 204-38-08 / serial# (b)(4).Distal femoral augment sz 3, 10 mm (cat# 208-06-03 / serial# (b)(4).Stem extension w/slot 120 x 16 mm (cat# 204-36-12 / serial# (b)(4).
Event or Problem Description
As reported, approximately 8 yrs postop the initial implant, the right cck liner was replaced by a new cck implant in this this male patient.Surgeon suspected that it is the backing of the stuffing screw caused the components to separate during range of motion and result in instability.Patient was last known to be in stable condition following the event.The device is not returning for evaluation due to hospital disposed the device.
Additional Manufacturer Narrative
The evaluation noted that revision reported was likely the result of the spine stiffening screw backing out of the tibial stem extension, which ultimately resulted in instability.However, the reason for the screw disengagement could not be determined as the explants were not available for evaluation and x-rays were not provided.The most probable root cause associated with the reported event of "disassembled / misassembled" is associated with the unwanted disassembly of the device, or incorrect assembly of the device (attaching mating instrumentation incorrectly, assembling an implant construct off-axis, etc.).Section : brand name section : model number, catalog number, serial number, expiration date, unique identifier (udi) # section : device manufacture date.

• Brand Name: CC TIBIAL INSERT SZ 3, 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11474822
• Report Number: 1038671-2021-00108
• Device Sequence Number: 3705572
• Product Code: JWH
• UDI-Device Identifier: 10885862054265
• UDI-Public: 10885862054265
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2021

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: 10/17/2015
• Device Model Number: CC TIBIAL INSERT SZ 3, 13MM
• Device Catalogue Number: 208-23-13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 05/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability