MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-44-2009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial right tka on (b)(6) 2020.The patient was revised on (b)(6) 2024 due to femur loosening from poly, and patella wear.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending investigation.D10: (b)(6) - 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t.(b)(6) - 201-78-15 - holding pin mini sharp point 4 pk.(b)(6) - 201-78-81 - 3 trocar, mod.Hex 2pk.(b)(6) - 521-78-23 - threaded pin size 2.3 collared.(b)(6) - 521-78-23 - threaded pin size 2.3 collared.(b)(6) - 521-78-32 - threaded pin size 3.0 collarless.(b)(6) - a10012 - gps implant kit v2.
Additional Manufacturer Narrative
H2: the reason for the revision cannot be confirmed from the information provided but may be due to prosthesis wear and femoral loosening as reported, patient conditions, or inclusion of the implanted polyethylene in the packaging recall.However, this cannot be confirmed as the devices were not returned for evaluation.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 9MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 111111-1111
• MDR Report Key: 19806016
• Report Number: 1038671-2024-02480
• Device Sequence Number: 8348865
• Product Code: JWH
• UDI-Device Identifier: 10885862173478
• UDI-Public: 10885862173478
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2024

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: 06/06/2024
• Device Catalogue Number: 02-012-44-2009
• 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: 04/04/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 08/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2016
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Age: 66 YR
• Patient Sex: Female
• Patient Weight: 82 KG