MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 3, 9MM, SLOPE +; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	CR TIBIAL INSERT SZ 3, 9MM, SLOPE +
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Swelling/ Edema (4577)
Date of Event	03/05/2026
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, sales rep informed that there is a plan that the recall insert will retrieve at revision surgery around week after next due to posterior wear of the insert.
Additional Manufacturer Narrative
(h3) the prosthesis wear reported may have been the result of excessive posterior slope of the tibial components, which led to posterior wear of the insert.This cannot be confirmed because it is unclear if the patient has been revised and not enough information (images, x-rays, etc.) has been provided.Additionally, a contributing factor to the wear may have been the result of the insert being packaged in a non-conforming vacuum bag for more than five years.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 information.The following sections were updated: a2, a3, b1, b2, b4, d10, e1, e3,g1,g4, h1, h6, h11 should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
The revision occurred.The patient who had a right tka using a cr slope+ tibial insert complained of knee swelling and pain.The surgeon diagnosed the wear of the tibial insert.The revision surgery for the replacement of the tibial insert was performed.Breakage and wear were observed in the retrieved tibial insert as well as tibial tray.The surgeon decided that the insert and tibial tray only were replaced with a new crc size 3 13 mm neutral insert and tibial tray 3f/2t.There was device breakage, which was retrieved from the wound site.Polyethylene particles were removed by the surgeon appropriately.There were no surgical delays reported.The patient was last known to be in stable condition following the event.No x-rays were provided.The explanted devices are not available for return.Device images were provided.No further information.This is 1 of 2 reports for this event.

• Brand Name: CR TIBIAL INSERT SZ 3, 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: ashley harris ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 13005620
• Report Number: 1038671-2021-00699
• Device Sequence Number: 5040639
• Product Code: JWH
• UDI-Device Identifier: 10885862041067
• UDI-Public: 10885862041067
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2026

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: 07/22/2021
• Device Model Number: CR TIBIAL INSERT SZ 3, 9MM, SLOPE +
• Device Catalogue Number: 200-63-09
• 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: 11/19/2021
• Supplement Date Received by Manufacturer: 09/15/2022; 03/11/2026
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 10/10/2022; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2013
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 100 KG