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

Model Number	LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately two years post initial right side tka, this (b)(6) y/o female patient had a revision due to increase wear of the polyethylene insert.There was no breakage of the device.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.The device is available for evaluation.
Additional Manufacturer Narrative
Concomitant medical products: logic cr femoral por, left, sz 2.5 (cat# 02-010-04-0225 / serial#: (b)(4)).Lgc tibial fit tray cem sz 2.5f / 5t (cat# 02-012-45-2525 / serial# : (b)(4)).Three peg patella 35mm (cat# 200-02-35 / serial#: (b)(4)).Logic cr femoral por, right, sz 2.5 (cat# 02-010-04-0325 / serial#: (b)(4)).Lgc tibial fit tray cem sz 2.5f / 5t (cat# 02-012-45-2525 / serial#: (b)(4)).Logic tibial insert std, sz 2.5, 9 mm (cat# 02-012-47-2509 / serial#: (b)(4)).Three peg patella 35mm (cat# 200-02-35 / serial#: (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections d9, g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported was likely the result of axial rotation mismatch of the femoral component relative to the tibial insert and third body wear, which led to wear of the polyethylene.Additionally, a contributing factor to the wear and delamination may have been the result of being packaged in a non-conforming vacuum bag for more than five years.The most probable root cause associated with the reported event of "prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.Section d4: serial number, expiration date, unique identifier (udi) # section h4: device manufacture date.
Additional Manufacturer Narrative
Additional information: a2, b5, b6, & b7 h7.Recall yes [number was reported in h9].
Event or Problem Description
Additional information received via the legal department- [revision right total knee replacement on (b)(6) 2022] there were no post operative complications, and she was discharged the next day and attended physiotherapy and hydrotherapy.By the end of (b)(6) 2022, the patient noticed significant improvement in her symptoms with subsidence of pain, stiffness and swelling in the right knee.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 13565358
• Report Number: 1038671-2022-00208
• Device Sequence Number: 5947559
• Product Code: JWH
• UDI-Device Identifier: 10885862159144
• UDI-Public: 10885862159144
• 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: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2023

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: 08/30/2021
• Device Model Number: LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM
• Device Catalogue Number: 02-012-47-2509
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2022
• Supplement Date Received by Manufacturer: 08/24/2022; 03/16/2023
• Initial Report FDA Received Date: 02/19/2022
• Supplement Report FDA Received Date: 09/24/2022; 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2013
• 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: 68 YR
• Patient Sex: Female