MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CR TIBIAL INSERT SZ4, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	12/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During the week of april 17-25, representatives of exactech, inc.And exactech spain conducted an in-person site visit with (b)(6) hospital.As a result of that site visit and at exactech's request, the hospital provided a retrospective excel listing of revision related to polyethylene wear that have been performed since 2010.These cases have not previously been reported to exactech as complaints.On (b)(6) 2023 updates to the excel listing were provided.This 71 year-old male patient was implanted with a (cr tibial insert sz4, 9mm cat# 200-24-09 / serial# (b)(6) on (b)(6) 2014.The insert was manufactured on 26-apr-2011 and was packaged in a vacuum bag with no evoh.The insert was 2.73 years shelf age at the time of implant.On (b)(6) 2022, approximately nine years post implantation, the patient underwent revision for wear of the polyethylene.There was clear signs of polyethylene wear.Patient was revised to a competitor¿s device.
Additional Manufacturer Narrative
Section d10: concomitant products - bandeja tibial logic fit 2f/3t (cat# 02-012-45-2030 / serial# (b)(6) - bandeja tibial logic fit 4f/4t (cat# 02-012-45-4040 / serial# (b)(6)- disc ins c/ceja 28-g0 (cat# 132-28-50 / serial# (b)(6) - disc cabeza ceramica 28 mm 0 mm (cat# 140-28-00 / serial# (b)(6) - vastago element s/collar offset ext.Nº 9 (cat# 164-02-09 / serial# (b)(6) - disc cot orificios agrupados 46mm (ha) (cat# 180-11-46 / serial# (b)(6)- inserto tib cr 2, 13mm (cat# 200-22-13 / serial# (b)(6) - vastago ext.14x40mm (cat# 204-34-04 / serial# (b)(6) - tornillo fijacion vástago a tibia (cat# 204-70-00 / serial# (b)(6) - comp.Femoral asimetrico poroso cr nº2 dcha (cat# 232-03-02 / serial# (b)(6) - comp.Femoral asimetrico poroso cr nº4 dcha (cat# 232-03-04 / serial# (b)(6) additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be due to polyethylene wear as reported.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, the reported polyethylene wear cannot be confirmed as the devices were not available for evaluation and radiographs/ photographs and operative notes were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6 clinical code, investigation findings, investigation conclusions.

• Brand Name: CR TIBIAL INSERT SZ4, 9MM
• 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
• MDR Report Key: 18332552
• Report Number: 1038671-2023-02983
• Device Sequence Number: 12447709
• Product Code: JWH
• UDI-Device Identifier: 10885862040299
• UDI-Public: 10885862040299
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/25/2025

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: 04/25/2019
• Device Model Number: CR TIBIAL INSERT SZ4, 9MM
• Device Catalogue Number: 200-24-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 05/27/2024; 04/14/2025
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 06/11/2024; 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2011
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 109 KG