MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	02-012-44-3011
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Breast Discomfort/Pain (4504); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	04/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported via legal documentation, a patient had right knee replacement on (b)(6)2014.They underwent right knee revision on (b)(6)2023, approximately 8 years 4 months post primary procedure.The patient has claimed injuries including but not limited to pain and discomfort; swelling; gait impairment; poor balance; and other injuries presently undiagnosed.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
This follow-up report is being submitted to relay added and/or corrected information.The following sections were added: b1, b2, d1, d4, d10, g1, h4, h6 component code and investigation codes.The following sections were corrected: h6 clinical codes, medical device problem code.D10: 02-010-01-0330 - logic femoral ps cem right sz 3 (3601221) 02-012-41-3030 - logic tibia traptray cem sz 3f/3t (3660508) 200-02-32 - three peg patella 32mm (3738860) the product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.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: h6.Mdr section codes updated/corrected: b, c, d, e.The reason for the underlying pain leading to the revision reported cannot be determined.The articular surface had several pits consistent with third body wear and wear of the medial posterior edge of the tibial insert spine was noted on the returned device; however, the extent of wear was unremarkable for the length of implantation.Prosthesis wear and/or inclusion of the insert in the packaging recall may have been a contributing factor to the reason for revision.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17465639
• Report Number: 1038671-2023-01871
• Device Sequence Number: 7236916
• Product Code: JWH
• UDI-Device Identifier: 10885862173560
• UDI-Public: 10885862173560
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2025

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
• Device Expiration Date: 09/08/2022
• Device Catalogue Number: 02-012-44-3011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2023
• Supplement Date Received by Manufacturer: 03/18/2025; 07/31/2025
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 04/29/2025; 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2014
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown