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

Model Number	CR TIBIAL INSERT SZ 4, 9MM, SLOPE +
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	05/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: optetrak asy,cr cemented femoral, sz 4 (cat# 230-02-04 / serial# (b)(4)) lgc tibial fit tray cem sz 4f/4t (cat# 02-012-45-4040 / serial# (b)(4)) one peg patella (cat# 200-03-38 / serial# (b)(4)) optetrak asy,cr cemented femoral, sz 4 (cat# 230-02-04 / serial# (b)(4)) additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 7.5 yrs postop the initial implant, the male patient was revised found catastrophic poly failure with massive osteolysis of the right knee.Patient was last known to be in stable condition following the event.The device will not be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported was likely the result of excessive posterior contact, especially medially, which led to wear and fracture of the polyethylene and tibial tray.Contributions from a combination of axial rotation mismatch of the femoral component relative to the tibial insert, the overall posterior slope of the tibial insert, and pcl tensioning to the condition of the polyethylene cannot be determined from the provided information.Prosthesis wear may have contributed to particle-induced osteolysis and if the patient was lost to regular follow-up, the osteolysis may have progressed unnoticed.The most probable root cause associated with the reported event of "prosthesis fracture" is associated with a partial or full-thickness crack in the device materials, either during implantation or sometime after.Do not use if broken device is a screw.
Additional Manufacturer Narrative
After further review of additional information received the following sections d10, g2, g3, g6 and h2 have been updated accordingly.Section d10: concomitant medical products lgc tibial fit tray cem sz 4f/4t (serial# (b)(6)), one peg patella (serial# (b)(6)), optetrak asy,cr cemented femoral, sz 4 (serial# (b)(6)) section d6b: explanted date.

• Brand Name: CR TIBIAL INSERT SZ 4, 9MM, SLOPE +
• 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: 12143668
• Report Number: 1038671-2021-00334
• Device Sequence Number: 4752349
• Product Code: JWH
• UDI-Device Identifier: 10885862041104
• UDI-Public: 10885862041104
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/27/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/17/2015
• Device Model Number: CR TIBIAL INSERT SZ 4, 9MM, SLOPE +
• Device Catalogue Number: 200-64-09
• 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: 06/01/2021
• Supplement Date Received by Manufacturer: 03/11/2022; 05/10/2022
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 04/04/2022; 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2010
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male