MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 2, 9MM, SLOPE ++; SEE H10

Model Number	200-72-09
Medical Device Problem Codes	Material Integrity Problem (2978); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Joint effusion (4849)
Date of Event	03/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Additional information received by the legal department on (b)(6) 2023 : on (b)(6) 2023 , the patient underwent a left total knee replacement.On (b)(6) 2017, the patient underwent revision of the exactech knee device secondary to polyethylene liner wear with resulting osteolysis, liner breakage, and aseptic loosening.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Procodes: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitant medical products: 2429019 200-02-32 - three peg patella 32mm; 2559397 204-04-22 - trapezoid tibial tray sz 1f/2t, 2f/2t; 2382142 230-02-02 - optetrak asy,cr cemented femoral, sz 2.Initial mdr and fu1 reported under mfr# 1038671-2017-00216 reported under historical system, prior to electronic complaint handling system.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported in experience was likely the result of excessive overall posterior tibial slope of the tibial insert (as defined by the combination of the posterior slope of the proximal tibial cut and the built-in slope of the insert) and/or axial rotation misalignment between the femoral component and the tibial tray, which allowed for excessive posterior contact between the femoral component and the tibial insert mainly on the medial aspect leading to catastrophic wear of the uhmwpe tibial insert.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 SZ 2, 9MM, SLOPE ++
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16617385
• Report Number: 1038671-2023-00512
• Device Sequence Number: 7325082
• Product Code: JWH
• UDI-Device Identifier: 10885862041210
• UDI-Public: 10885862041210
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2018
• Device Model Number: 200-72-09
• Device Catalogue Number: 200-72-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2010
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male