MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-23-09
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	05/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): 5582059, 02-010-04-0330 - logic cr femoral por, right, sz 3.5665950, 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t.5592507, 200-02-35 - three peg patella 35mm.
Event or Problem Description
As reported, approximately 4 years post op initial right tka, this 63 y/o female patient was revised due to poly wear.Patient was last known to be in stable condition following the event.Unable to obtain x-rays.Product not returning: hospital disposed of them.No further information provided.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported is most likely the result of polyethylene wear.However, while the wear appears to be confirmed on the provided images, the contributions of implant positioning, patient-related conditions, and/or other potential factors to the reported event cannot be determined as the device was not returned for evaluation and limited information was available.Section h11: *the following sections have corrected information: (h6) component code: 734, bearings.
Event or Problem Description
As reported, approximately 4 years post op initial left tka, this 63 y/o female patient was revised due to poly wear.Patient was last known to be in stable condition following the event.Unable to obtain x-rays.Product not returning: hospital disposed of them.No further information provided.
Additional Manufacturer Narrative
*the following sections have corrected information: b5, d1, d4, h4, h6.D11: concomitants: 200-02-35 three peg patella, 35mm 2575249.200-04-33 cemented finned tray 3f/3t 2714060.232-02-03 cr porous femoral size 3, left 2729028.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported is likely the result of prosthesis wear or due to inclusion of the polyethylene in the packaging recall.While wear appears to be confirmed on the provided images, potential contributions of implant positioning, user-related considerations, and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and radiographs and relevant clinical information 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 SZ3, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17144912
• Report Number: 1038671-2023-01381
• Device Sequence Number: 12216857
• Product Code: JWH
• UDI-Device Identifier: 10885862040244
• UDI-Public: 10885862040244
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/07/2025

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: 12/07/2017
• Device Catalogue Number: 200-23-09
• 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: 05/30/2023
• Supplement Date Received by Manufacturer: 08/14/2023; 11/15/2024; Not provided
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 09/06/2023; 12/10/2024; 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2009
• 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-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 63 YR
• Patient Sex: Female