MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 2, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-22-11
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	08/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
This 71 y/o, female patient underwent initial tka of the right knee on (b)(6) 2015 and was implanted with a cr insert tibial size 2, 11mm (cn: 200-22-11, sn: (b)(6).On (b)(6) 2021 the patient¿s right knee was revised due to unknown reasons.During the revision, clear asymmetry of the polyethylene caused by wear was noted.It was decided to do the revision in 2 stages.During this first stage a cement spacer (only) was placed.Later on (b)(6) 2021, the patient underwent the second stage of the revision.At this time, it was noted that the patient had significant osteolysis and bone loss in the tibia and both condyles.The surgeon felt that this was related to asymmetrical wear of the polyethylene insert.The patient was revised to a johnson & johnson sigma tka system with ¿sleeves".
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation: (d10) concomitant device(s): 3924594 02-012-45-2020 - bandeja tibial logic fit 2f/2t.3932745 232-03-02 - comp.Femoral asimetrico poroso cr nº2 dcha.
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear and osteolysis.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.Additionally, a contributing factor may have been the result of being packaged in a non-conforming vacuum bag for more than five years.The extent and root cause of the prosthesis wear and osteolysis could not be determined as the devices were not returned, and images and radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b5.G: reporting contact - name and email.H6: health effect - clinical code, investigation findings, investigation conclusions.
Event or Problem Description
It was reported that this patient's right tka (total knee arthroplasty) was revised approximately 6 years post initial operation.The patient was revised due to unknown reasons.During the revision, clear asymmetry of the polyethylene caused by wear was noted.It was decided to do the revision in 2 stages.During this first stage a cement spacer (only) was placed.Then 6 months later, the patient underwent the second stage of the revision.At this time, it was noted that the patient had significant osteolysis and bone loss in the tibia and both condyles.The patient was revised to a competitors device.

• Brand Name: CR TIBIAL INSERT SZ 2, 11MM
• 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: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18106961
• Report Number: 1038671-2023-02735
• Device Sequence Number: 7863197
• Product Code: JWH
• UDI-Device Identifier: 10885862040206
• UDI-Public: 10885862040206
• 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: 2015
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/21/2018
• Device Catalogue Number: 200-22-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 12/04/2023; 06/20/2025
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 12/20/2023; 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2010
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Sex: Female