MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 2.5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC TIB INSERT IMPL CRC, SZ 2.5, 11MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, this (b)(6) y/o female patient, weight (b)(6) lbs., had knee pain 2 years out following a left total knee.The surgeon scoped the knee a month back and noticed that the poly was worn and broken and planned a revision to take the poly out and exchanging it.Patient had the broken size 2.5 crc by 11 mm poly removed and replaced with a size 12mm poly.Patient was last known to be in stable condition following the event.The device will be returned.
Additional Manufacturer Narrative
After further review of additional information received the following sections d10, g3, g7 and h2 have been updated accordingly.Section d10: concomitant medical products: - tibial stem ext.Screw (cat# 204-70-00 / serial# (b)(6).- logic cr femoral cem, left sz 2.5 (cat# 02-010-03-0225 / serial# (b)(6).- three peg patella 35mm (cat# 200-02-35 / serial# (b)(6).- fluted stem extension 40l x 14 mm (cat# 204-34-04 / serial# (b)(6).- lgc tibial fit tray cem sz 2.5f / 2.5t (cat# 02-012-45-2525 / serial# (b)(6) section d1: brand.Name section d4: model number, catalog number, expiration date, unique identifier (udi) #.Section h4: device manufacture date.
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 excessive wear of the tibial insert, malrotation of the tibial components, and excessive tibial slope, which led to joint pain.This insert was packaged in a non-conforming vacuum bag for more than five years, which may have contributed to the severe wear and delamination observed.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.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 2.5, 11MM
• 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 12170683
• Report Number: 1038671-2021-00341
• Device Sequence Number: 3858029
• Product Code: JWH
• UDI-Device Identifier: 10885862158000
• UDI-Public: 10885862158000
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2022

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: 04/05/2021
• Device Model Number: LOGIC TIB INSERT IMPL CRC, SZ 2.5, 11MM
• Device Catalogue Number: 02-012-51-2511
• 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: 06/25/2021
• Supplement Date Received by Manufacturer: 07/22/2021; 03/10/2022
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 07/26/2021; 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2013
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 107 KG