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

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	10/21/2021
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 female patient's right knee was revised due to poly wear.The poly is greater than 5 years old at the time of implantation.No other information available at this time.
Additional Manufacturer Narrative
After further review of additional information received the following sections d6b, d10, g3, g6, h2, h3 and h6 have been updated accordingly.Section d10: concomitant medical products - logic cr femoral cem, left sz 2.5 (cat# 02-010-03-0225 / serial# (b)(6).- lgc tibial fit tray cem sz 2.5f / 2.5t (cat# 02-012-45-2525 / serial# (b)(6).- three peg patella 32mm (cat# 200-02-32 / serial# (b)(6).- threaded pin size 2.6 collarless 2pk (cat# 521-78-31 / serial# (b)(6).(h3) the revision reported was likely the result of a combination of patient conditions, imbalanced flexion gaps, and malpositioning of the implants, which allowed for excessive posterior contact of the femoral component on the tibial insert and led to wear of the polyethylene insert.Additionally, a contributing factor to the wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.However, this cannot be confirmed as the devices were not available for evaluation.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 CR TIB INSERT STD, SZ 2.5, 9 MM
• 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: 12787949
• Report Number: 1038671-2021-00609
• Device Sequence Number: 12050920
• Product Code: JWH
• UDI-Device Identifier: 10885862159144
• UDI-Public: 10885862159144
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2022

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: 08/16/2019
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2011
• 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: Required Intervention
• Patient Sex: Female