MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE +, SZ 2.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT SLOPE +, SZ 2.5, 9 MM
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	07/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 02-010-03-0325 - logic cr femoral cem, right, sz 2.5, 5455297; 02-012-45-2515 - lgc tibial fit tray cem sz 2.5f / 1.5t, 5452256; 200-02-29 - three peg patella 29mm, 5406336.
Event or Problem Description
As reported, the patient had an initial right tka on (b)(6) 2018.The patient had a poly swap and was last known to be in stable condition following the event.No other patient information or medical history provided.
Additional Manufacturer Narrative
H3: 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 poly swap/revision was reported to be due to device recall.No other reason reported.H7: z-0021-2022.
Event or Problem Description
As reported via legal documentation, a patient had right replacement surgery on (b)(6) 2018.They subsequently underwent right knee revision surgery on (b)(6) 2022, approximately 4 years post primary procedure.On (b)(6) 2022 op report states that the patient did have a large effusion with no evidence of purulence or metallosis.There was hypertrophy of the synovium present.Surgeon noted that they could easily appreciate deformation fracture and pinning of the medial femoral condyle of the tibial plastic.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Additional information provided via legal documentation required a new investigation.H3.Updated investigation results- the revision reported in case-2022-00006190 was likely due to inclusion of the tibial insert in the packaging recall and prosthesis wear.It is possible that a contributing factor to the reported wear may have been the result of being packaged in a non-conforming bag for more than 5 years before it was implanted.The full extent and root cause of the prosthesis wear could not be confirmed as the device was not returned and, therefore, could not be evaluated.Images and radiographs were also not provided.These devices are used for treatment not diagnosis.There is no other information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d6b.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 corrected information.The following sections were corrected: b1, b2, d8, f10 (remove all from initial report), g2 (correcting initial report), h6: clinical codes, medical device problem code and types of investigation.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 SLOPE +, SZ 2.5, 9 MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15370303
• Report Number: 1038671-2022-01042
• Device Sequence Number: 6277867
• Product Code: JWH
• UDI-Device Identifier: 10885862159182
• UDI-Public: 10885862159182
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/10/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2020
• Device Model Number: LOGIC CR TIB INSERT SLOPE +, SZ 2.5, 9 MM
• Device Catalogue Number: 02-012-48-2509
• 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: 08/18/2022
• Supplement Date Received by Manufacturer: 10/12/2022; 09/18/2023; 01/26/2026; 02/10/2026
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 10/31/2022; 10/09/2023; 02/10/2026; 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2012
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female