MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-48-2009
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the legal department that this female patient's left knee will need to a revision surgery prematurely.
Additional Manufacturer Narrative
Pending evaluation.
Additional Manufacturer Narrative
Additional information: a2, b5, b7, d1, d4- all, d8, e3, g4, 510k, h6.H7 & h9.H6.Device evaluation- 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 planned revision cannot be conclusively determined, insufficient information.The patient has bilateral knee replacements, this suggests joint maladies.These devices are used for treatment not diagnosis.B6.Health effect - impact code, the patient has not been revised, there is no reported date for revision.
Event or Problem Description
Additional information received via legal.Initial implant op report of (b)(6) 2018 preoperative diagnosis: left knee osteoarthritis, severe the patient is a 56-year-old female with a history of bone-on-bone arthritis about the medial compartment about the left knee.At the completion of the surgical procedure the patient had bulky dressings applied, was awakened, and transferred to the recovery room in stable condition.No complications occurred throughout the case.Postoperative course: patient will remain admitted to the hospital for perioperative antibiotics, dvt prophylaxis, mobilization, and pain control.The patient hospital course was monitored, and she was to have mobilization to tolerance.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6 (component code, type of investigation).The following sections were corrected: h6 (health effect - clinical code, health effect - impact code, medical device problem code).The reason for the reported event cannot be confirmed from the information provided but may be due to prosthesis wear, instability, and loosening and/or inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.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+
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 16409153
• Report Number: 1038671-2023-00190
• Device Sequence Number: 20368951
• Product Code: JWH
• UDI-Device Identifier: 10885862174284
• UDI-Public: 10885862174284
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• 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,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/02/2025
• Device Catalogue Number: 02-012-48-2009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 04/11/2023; 12/18/2024
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 04/11/2023; 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female