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

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	08/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Email to complaints - spain ubarmin #92 during the week of april 17-25, representatives of exactech, inc.And exactech spain conducted an in person site visit with ubarmin 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 patient (b)(6) was implanted with a 200-24-09 cr tibial insert sz4, 9mm, serial number (b)(6) on (b)(6) 2011.The insert was manufactured on 4/26/2010 and was packaged in a vacuum bag with no evoh.The insert was manufactured on 4/26/2010 and was 0.89 years of shelf age at the time of implant.Patient was revised on (b)(6) 2023 approximately 12.45 years post implant.Massive lysis of the tibial plateau and internal femoral condyle.No additional details are available at this time.
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer d10: concomitants: 1944298 200-04-44 - cemented tib tray fin 4f/4t 1741403 232-02-04 - comp.Porous asymetric femoral cr nº4 izq additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: the revision reported is most likely the result of polyethylene wear and osteolysis over the course of 12.5 years of implantation.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
Corrected information: h6- health effect/clinical code, h6- component code, h6- investigation findings- 140/wear problem, 4243/packaging materials problem no longer apply, h6-investigation conclusions.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1/d2a/d2b, d4, h6.Mdr section codes updated/corrected: c.The revision reported in is most likely the result of polyethylene wear and osteolysis over the course of 12.5 years of implantation.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.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 SZ4, 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 court; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18352784
• Report Number: 1038671-2023-03022
• Device Sequence Number: 15129224
• Product Code: JWH
• UDI-Device Identifier: 10885862040299
• UDI-Public: 10885862040299
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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
• Report Date (Section B): 05/15/2025

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: 04/26/2018
• 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: 04/11/2024; 11/28/2023; 05/15/2025
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 04/15/2024; 11/07/2024; 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2010
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 77 KG