MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CC TIB INSERT SIZE 2, 25MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Catalog Number	UNKNOWN
Medical Device Problem Codes	Mechanical Problem (1384); Naturally Worn (2988)
Health Effect - Clinical Codes	Emotional Changes (1831); Loss of Range of Motion (2032); Discomfort (2330); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Implant Pain (4561); Swelling/ Edema (4577); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal the patient had a left knee revision on (b)(6) 2022.This revision was revised again in 2023 (exact date is unknown) the poly insert had completely disintegrated, so the tibia completely crumbled, and she had to get a tibial plate and screws inserted.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
D10: concomitants; 02-010-06-0220 - tru cc femoral size 2 left (b)(6).02-010-06-0522 - tru post.Aug.Size 2, 10mm (b)(6).02-010-66-1002 - metaphyseal femoral cone, small, h42mm (b)(6).02-012-45-2030 - lgc tibial fit tray cem sz 2f / 3t (b)(6).02-012-60-1416 - tru stem ext 14mm x 160mm (b)(6).02-012-60-1440 - tru stem ext 14mm x 40mm (b)(6).02-012-60-1880 - tru stem ext 18mm x 80mm (b)(6).02-012-66-2000 - metaphyseal tibial cone, ml32mm (b)(6).208-06-02 - cc distal fem augment sz 2, 10mm (b)(6).208-06-02 - cc distal fem augment sz 2, 10mm (b)(6).Cs-05cc - intersep calcium sulfate (b)(6).Pending investigation.
Additional Manufacturer Narrative
D4: removed catalog number, expiration date, serial number, and udi d10: concomitants unknown g3: removed 510k number h4: removed device manufacture date h6: corrected health effect - clinical code, medical device problem code, component code, type of investigation, investigation findings, and investigation conclusions.Manufacturer narrative updated: the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, loss of range of motion, loosening and/or due to inclusion of the polyethylene in the packaging recall.Additionally, the devices were implanted for over ten years prior to the reported failure(s).However, the reported prosthesis wear, loss of range of motion, and loosening could not 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 product information, images, radiographs, or relevant clinical information was provided.

• Brand Name: LOGIC CC TIB INSERT SIZE 2, 25MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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 ; 3523771140
• MDR Report Key: 17893896
• Report Number: 1038671-2023-02470
• Device Sequence Number: 19455795
• Product Code: JWH
• UDI-Device Identifier: 10885862265944
• UDI-Public: 10885862265944
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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: 01/30/2026
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2023
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2018
• 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
• Patient Sex: Female