MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 2, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT STD, SZ 2, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Synovitis (2094); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 4.5 years post initial right tka, this patient presented in clinic after receiving recall letter with pain, swelling, and x-ray indication of medial poly wear.Magnetic resonance imaging (mri) did not show loosening but did show synovitis.Surgeon performed revision.Surgeon used a osteotome to removed the old pins wet.The patient¿s insert was exchanged and knee washed out.The knee was stable with good range of motion (rom) with same size poly 9mm.Patient was last known to be in stable condition.Surgeon commented that the insert did not look extremely worn but did have some pitting and indention.X-ray received.The device is not available for evaluation due to patient will be collecting her old poly for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3, h6, h7 and h9 have been updated accordingly.(h3) the revision reported was likely the result of the patient¿s pain and swelling.Prosthesis wear of the tibial insert was also reported but appears minimal in the images provided.However, this cannot be confirmed because the revised tibial insert was not returned to exactech for evaluation.An additional contributing factor to the revision may have been inclusion of the tibial insert in the packaging recall.The most probable root cause associated with the reported event of ¿prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: d, e, g.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of the patient¿s pain and swelling.Prosthesis wear of the tibial insert was also reported but appears minimal in the images provided.However, this cannot be confirmed because the revised tibial insert was not returned to exactech for evaluation.An additional contributing factor to the revision may have been inclusion of the tibial insert in the packaging recall.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 2, 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14167585
• Report Number: 1038671-2022-00445
• Device Sequence Number: 20089749
• Product Code: JWH
• UDI-Device Identifier: 10885862174246
• UDI-Public: 10885862174246
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/16/2025

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: 03/06/2025
• Device Model Number: LOGIC CR TIB INSERT STD, SZ 2, 9MM
• Device Catalogue Number: 02-012-47-2009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 03/31/2023; 03/04/2025; 04/15/2025
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 04/17/2023; 03/05/2025; 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2017
• 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-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: - HOLDING PIN HEADLESS 3" (4 PK); - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T; - LOGIC CR FEMORAL CEM, RIGHT, SZ 2; - THREE PEG PATELLA 32MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown