MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT SLOPE++, SZ 5, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 3.5 years post initial left tka, the 70 y/o male patient had a revision due to poly wear.Patient had a liner was exchanged.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images received.The devices are not available for evaluation as they were discarded by the hospital.
Additional Manufacturer Narrative
Section d10: concomitant products: lgc tibial fit tray cem sz 5f / 5t (cat# 02-012-45-5050 / serial# (b)(6)).Logic cr femoral por, left, sz 5 (cat# 02-010-04-0250 / serial# (b)(6)).Three peg patella 41mm (cat# 200-02-41 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: the revision reported may have been the result of malalignment between the femoral and tibial components, third body wear, patient-related conditions, instability, or any combination of these possibilities, which led to wear of the polyethylene insert.However, this cannot be confirmed because the component was not returned for evaluation and radiographs were not provided.Additionally, the insert was packaged in a non-conforming vacuum bag for over five years, which may have contributed to the reported wear.

• Brand Name: LOGIC CR TIB INSERT SLOPE++, SZ 5, 9MM
• 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
• MDR Report Key: 18052119
• Report Number: 1038671-2023-02654
• Device Sequence Number: 20352272
• Product Code: JWH
• UDI-Device Identifier: 10885862174611
• UDI-Public: 10885862174611
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/13/2022
• Device Model Number: LOGIC CR TIB INSERT SLOPE++, SZ 5, 9MM
• Device Catalogue Number: 02-012-49-5009
• 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: Not provided
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 04/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2014
• 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
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 107 KG