MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	LOGIC TIB INSERT IMPL CRC, SZ 4, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 4" trocar, mod hex 2 pk (cat# 201-78-87 / serial# (b)(4) ) 3" trocar, hex 2pk (cat# 201-78-80 / serial# (b)(4) ) holding pin mini sharp point 4 pk (cat# 201-78-15 / serial# (b)(4) ) 3" trocar, hex 2pk (cat# 201-78-80 / serial# (b)(4) ) 3" trocar, mod.Hex 2pk (cat# 201-78-81 / serial# (b)(4) ) additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 5 months postop the initial right tka, the right knee was revised due to knee instability.On examination increase poly wear was found, new 9mm cr neutral insert was implanted.Patient was last known to be in stable condition following the event.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received.(h3) the evaluation noted that revision reported was likely the result of a combination of a post traumatic event which resulted in the patient falling ¿heavily on both knees.¿ progressive instability, and third body wear, which led to wear of the polyethylene insert.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.Furthermore, the most probable root cause associated with the reported event of "post traumatic event" is associated with an event that damages the device, such as a fall, car accident, or other event that does not appear to have been caused by the device or the implantation of the device.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 4, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11778862
• Report Number: 1038671-2021-00213
• Device Sequence Number: 3894272
• Product Code: JWH
• UDI-Device Identifier: 10885862040299
• UDI-Public: 10885862040299
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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: 03/17/2025
• Device Model Number: LOGIC TIB INSERT IMPL CRC, SZ 4, 9MM
• Device Catalogue Number: 02-012-51-4009
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 73 YR