MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 4, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CC TIBIAL INSERT SZ 4, 15MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: lgc tibial fit tray cem sz 4f / 4t (cat# 02-012-45-4040 / serial# (b)(4)) ,logic pts, size 4, 8mm (cat# 02-012-42-4008 / serial# (b)(4)) , cc stem ext adaptor 5 degree (cat# 208-09-05 / serial# (b)(4)) ,cc posterior fem augment sz 4, 5mm (cat# 208-07-04 / serial# (b)(4)) ,cc distal fem augment sz 4, 5mm (cat# 208-05-04 / serial# (b)(4)) , screw, offset, sz ee (cat# 208-04-73 / serial# (b)(4)) ,cc femoral sz 4 (cat# 208-01-04 / serial# (b)(4)) ,stem extension 80l x20 mm (cat# 204-40-08 / serial# (b)(4)) , and stem extension 80l x16 mm (cat# 204-36-08 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately five years post initial left tka, this male patient had a revision due to knee failed and instability.There was poly wear and osteolysis per viewing the poly and surgeon input.Patient was revised to competitor's hinge.There was no breakage of device.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Photos and x-rays received.The device will be return.
Additional Manufacturer Narrative
The revision reported was likely the result of malalignment between the femoral and tibial components, imbalanced flexion and extension gaps, patient-related conditions, or any combination of these possibilities, which led to gross joint instability, wear/delamination of the tibial insert, and osteolysis.The most probable root cause associated with the reported event of "instability¿ is associated with undesirable stability of the joint or implant construct.
Additional Manufacturer Narrative
After further review of additional information received the following sections d9, g3 and h3 have been updated accordingly.Additional information, including the product investigation, will be submitted within 30 days of receipt section d1: brand name section d4: model number, catalog number, serial number, expiration date, unique identifier (udi) #.Section h4: device manufacture date.Section d10: concomitant medical products.Screw, offset, sz gg (cat# 208-04-75 / serial# (b)(6)).

• Brand Name: CC TIBIAL INSERT SZ 4, 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: 14054343
• Report Number: 1038671-2022-00391
• Device Sequence Number: 4987299
• Product Code: JWH
• UDI-Device Identifier: 10885862054357
• UDI-Public: 10885862054357
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• 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): 12/07/2022

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: 04/21/2020
• Device Model Number: CC TIBIAL INSERT SZ 4, 15MM
• Device Catalogue Number: 208-24-15
• 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: 03/21/2022
• Supplement Date Received by Manufacturer: 09/13/2022; 11/16/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 09/13/2022; 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male