MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ4, 9MM; SEE H10

Model Number	CR TIBIAL INSERT SZ4, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Osteolysis (2377); Insufficient Information (4580)
Date of Event	07/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer d10: concomitants: (b)(6) - 02-012-45-4040 - bandeja tibial logic fit 4f/4t.(b)(6) - 200-24-09 - inserto tibial cr 4, 9mm.(b)(6) - 232-03-04 - comp.Femoral asimetrico poroso cr nº4 dcha.(b)(6) - 02-012-45-4040 - bandeja tibial logic fit 4f/4t.(b)(6) - 232-02-04 - comp.Femoral asimetrico poroso cr nº4 izq.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
(b)(6) #81 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 28-nov-2023 updates to the excel listing were provided.This patient (b)(6) was implanted with a 200-24-09 cr tibial insert sz4, 9mm, serial number (b)(6) on (b)(6) 2016.The insert was manufactured on 4/24/2015 and was packaged in a vacuum bag with no evoh.The insert was manufactured on 4/24/2015 and was 0.80 years of shelf age at the time of implant.Patient was revised on (b)(6) 2023 approximately 7.47 years post implant.He has two primary implanted prostheses.The left one is replaced and the right one is in good condition (it has no evoh bag).Femur defect posterior condyles and bone defect in tibia.J&j is implanted with pods.No additional details are available at this time.
Additional Manufacturer Narrative
H3: the revision reported may have been the result of polyethylene 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.The extent and root cause of the reported polyethylene wear and osteolysis cannot be determined as the explanted devices were not returned for evaluation, and radiographs, photographs, or operative notes were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h6 clinical code, component code, investigation findings, and conclusion.The following sections were corrected: h6 clinical code 4580, 4756, 4243, 140, 67, 22 no longer applies.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h3 - the revision reported was likely the result of prosthesis wear and osteolysis.The prosthesis wear may have occurred as a result of the osteolysis, or the wear particles from the insert could have contributed to the osteolysis, however, the sequence of events leading to the wear and reported osteolysis cannot be confirmed.Additional reasons for the reported revision may be inclusion of the polyethylene in the packaging recall.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.H6 the following sections were corrected: h6 - 4315 no longer applies.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3, d1, h4, h6.Mdr section codes updated/corrected: b, d.The revision reported was likely the result of prosthesis wear and osteolysis.The prosthesis wear may have occurred as a result of the osteolysis, or the wear particles from the insert could have contributed to the osteolysis, however, the sequence of events leading to the wear and reported osteolysis cannot be confirmed.Additional reasons for the reported revision may be inclusion of the polyethylene in the packaging recall.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.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: CR TIBIAL INSERT SZ4, 9MM
• Common Device Name: SEE H10
• 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: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18352625
• Report Number: 1038671-2023-03020
• Device Sequence Number: 6703049
• 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: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/20/2025

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: 04/23/2023
• 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: 11/28/2023; 04/14/2025; 06/17/2025; 11/20/2025
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 04/01/2024; 04/18/2025; 07/14/2025; 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2015
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 87 KG