MAUDE Adverse Event Report: EXACTECH, INC. LOGIC; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	LOGIC CR TIB INSERT SLOPE+, SZ 2, 11MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	08/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device return anticipated due to this being a legal case.Concomitant medical products: (b)(4), 02-010-03-0320 - logic cr femoral cem, right, sz 2.(b)(4), 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t.(b)(4), 200-02-29 - three peg patella 29mm.Recall number: z-0021-2022.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via a legal notification, that a female patient, initial right knee arthroplasty with an optetrak device, including a size 2, 11 mm optetrak logic tibial inserts made of polyethylene, performed on (b)(6) 2019, has had, and continues to have pain and swelling in her right knee.Plaintiff¿s treating physician has recommended she undergo a revision surgery as her ¿tka [is] worrisome for premature poly[ethylene] wear¿.
Event or Problem Description
It is mentioned that the patient had a revision, date not reported.No additional information.
Additional Manufacturer Narrative
H6: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision for pain cannot be conclusively determined, however, it is most likely related to the patient¿s underlying condition.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h3, h6, h11.A review of complaint history determined that no further action is required as no trends were identified.The reason for the reported adverse event cannot be confirmed from the information provided but may be the result of instability, prosthesis wear and component loosening or due to inclusion of the polyethylene in the packaging recall.A contributing factor to the reported wear on the tibial insert may have been due to the revised tibial insert having been packaged in a non-conforming bag for five years.However, the reported instability, prosthesis wear and component loosening cannot be confirmed and potential contributions of manufacturing, user, or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images radiographs, or relevant clinical information were provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: LOGIC
• 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 ; 3523771140
• MDR Report Key: 15595069
• Report Number: 1038671-2022-01302
• Device Sequence Number: 2136203
• Product Code: JWH
• UDI-Device Identifier: 10885862174291
• UDI-Public: 10885862174291
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2026

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: 11/29/2019
• Device Model Number: LOGIC CR TIB INSERT SLOPE+, SZ 2, 11MM
• Device Catalogue Number: 02-012-48-2011
• 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: 09/16/2022
• Supplement Date Received by Manufacturer: 10/20/2022; 04/01/2026
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 11/14/2022; 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2011
• 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: Required Intervention
• Patient Sex: Female