MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 3.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	LOGIC CR TIB INSERT STD, SZ 3.5, 9 MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evaluation noted that revision reported was likely the result of third body wear and rotational mismatch between the femoral and tibial components which led to prosthesis wear and instability.However, this cannot be confirmed because the component was not returned 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.
Event or Problem Description
As reported, approximately 4 years postop the initial l tka, the surgeon conducted a revision knee surgery that consisted of only a polyethylene swap that was placed in on (b)(6) 2017 for this male patient.The patient was complaining of instability and discomfort when walking up and down stairs.To address these concerns surgeon, replaced the size 3.5 (9mm) cr tibial insert with a size 3.5 (11mm) crc tibial insert.Upon removal of the old insert, it was noted that there was wear on the posterior-medial aspect of the insert.Patient was last known to be in stable condition following the event.The device will not be returned for evaluation due to patient requested that the insert was returned to him post-op.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 3.5, 9 MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11653352
• Report Number: 1038671-2021-00166
• Device Sequence Number: 3657674
• Product Code: JWH
• UDI-Device Identifier: 10885862159243
• UDI-Public: 10885862159243
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/12/2021

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: 08/16/2019
• Device Model Number: LOGIC CR TIB INSERT STD, SZ 3.5, 9 MM
• Device Catalogue Number: 02-012-47-3509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2021
• Initial Report FDA Received Date: 04/12/2021
• 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