MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC TIB INSERT IMPL CRC, SZ 5, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Implant Pain (4561); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	03/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, this male patient had a revision due to the implant was one of the recalled polys.Surgeon replaced worn poly with a new poly.The poly was severely delaminated and pitted.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.The device will be return.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections d1, d4, d6a, g3, g4, g6, h2, h3, h4, h6 and h9 have been updated accordingly.(h3) the revision reported was likely the result of mechanical overload on the posterior medial edge of the tibial insert due to unintended translational movement between the femoral and tibial components leading to wear of the polyethylene.However, contributions from patient-related conditions or positioning of the components to the wear cannot be determined as radiographs and additional clinical information was not available at the time of evaluation.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.
Event or Problem Description
Additional information received reported that the patient experienced continuous pain and swelling, recurrent effusions, bakers cyst, and chronic synovitis with foreign boy giant cell reaction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b5, h6 (clinical codes).
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, h6.Mdr section codes updated/corrected: a, b, c, e.The revision reported in was likely the result of mechanical overload on the posterior medial edge of the tibial insert due to unintended translational movement between the femoral and tibial components leading to wear of the polyethylene; however, contributions from patient-related conditions or positioning of the components to the wear cannot be determined as radiographs and additional clinical information was not available at the time of evaluation.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 following sections were updated/corrected: d1/d2a/d2b, h6.Mdr section codes updated/corrected: b, c, d, g.The revision reported was likely the result of mechanical overload on the posterior medial edge of the tibial insert due to unintended translational movement between the femoral and tibial components leading to wear of the polyethylene.However, contributions from patient-related conditions or positioning of the components to the wear cannot be determined as radiographs and additional clinical information was not available at the time of evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 5, 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 13944568
• Report Number: 1038671-2022-00309
• Device Sequence Number: 6505336
• Product Code: JWH
• UDI-Device Identifier: 10885862230560
• UDI-Public: 10885862230560
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K123342
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/26/2025

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: 01/01/2018
• Device Model Number: LOGIC TIB INSERT IMPL CRC, SZ 5, 9MM
• Device Catalogue Number: 02-012-51-5009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2022
• Supplement Date Received by Manufacturer: 09/23/2022; 06/19/2024; 06/25/2025; 06/25/2025
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 10/17/2022; 12/23/2024; 06/26/2025; 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2013
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male