MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 2, 9MM, SLOPE ++; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CR TIBIAL INSERT SZ 2, 9MM, SLOPE ++
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526); Metal Related Pathology (4530); Implant Pain (4561)
Date of Event	03/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported per legal team, the 77 y/o female patient that had an original knee replacement roughly 10 years ago.The patient is needing a full knee revision due to lysis on the bone and poly wear.
Additional Manufacturer Narrative
After further review of additional information received the following sections d1, d4, d6a, d6b, d10, g3, g4, g6, h2, h3, h4, h6, h7 and h9 have been updated accordingly.Section d10; concomitant products: - cemented finned tib.Tra sz 2f/3t (cat# 200-04-23 / serial# (b)(6)) - inset patella 23mm (cat# 200-05-23 / serial# (b)(6)) - optetrak asy,cr cemented femoral, sz 2 (cat# 230-03-02 / serial# (b)(6)) (h3) the revision reported may have been the result of the overall posterior slope of the insert and/or potential ligamentous/soft tissue imbalances, which allowed for increased posterior contact between the femoral component and the tibial insert and led to the reported tibial insert wear and subsequent posterior lateral tibial tray erosion.Additionally contributing factors to the reported wear and osteolysis include implant positioning, high contact stresses during knee flexion, third body wear, or any combination of these possibilities.However, the extent of the reported osteolysis/ prosthesis wear could not be determined as the explanted tibial insert was not available for evaluation, and pre-revision radiographs and images of the explanted devices were not provided.The most probable root cause associated with the reported event of ¿prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6 (component code).The following sections were corrected: h6 (health effect - clinical code, medical device problem code, investigation findings, investigation conclusions).The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and instability or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: CR TIBIAL INSERT SZ 2, 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: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16736632
• Report Number: 1038671-2023-00679
• Device Sequence Number: 6862348
• Product Code: JWH
• UDI-Device Identifier: 10885862041210
• UDI-Public: 10885862041210
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K082022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/21/2025

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: 11/04/2018
• Device Model Number: CR TIBIAL INSERT SZ 2, 9MM, SLOPE ++
• Device Catalogue Number: 200-72-09
• 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: 03/18/2023
• Supplement Date Received by Manufacturer: 10/03/2023; 01/15/2025
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 10/31/2023; 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2010
• 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
• 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 Age: 77 YR
• Patient Sex: Female