MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 1, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT SLOPE++, SZ 1, 13MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by legal brief, approximately 5 years post left tka, this (b)(6) female patient underwent left total knee arthroplasty revision for prothesis wear.The patient started having pain and associated dysfunction approximately about a year ago and workup ensued and was negative for infection through aspirin as well as lab work, then ct scans showed some lytic lesions concerning for particle disease.Patient was revised to competitor.The device is not available for evaluation.
Additional Manufacturer Narrative
Concomitant medical products: logic cr femoral cem, left sz 1 (cat# 02-010-03-0210 / serial# (b)(4)); lgc tibial fit tray cem sz 1f / 1t (cat# 02-012-45-1010 / serial# (b)(4)); three peg patella 29mm (cat# 200-02-29 / 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 g3, g6, h2, h3, h6 and h9 have been updated accordingly.(h3) the revision reported was likely the result of implanting a slope insert with a posteriorly inclined tibial tray, which may have led to excessive posterior slope and subsequent femoral articulation on the posterior edge of the insert.The reported pain and osteolysis may have been related to the observed delamination and fragmentation on the explanted tibial insert and/or patient-related conditions.However, this cannot be confirmed because the component was not available for evaluation and no x-rays were provided.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 "osteolysis¿ is associated with destruction or disappearance of bone tissue likely related to weakened integration of an implant at the bone-implant interface.

• Brand Name: LOGIC CR TIB INSERT SLOPE++, SZ 1, 13MM
• 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: 13795890
• Report Number: 1038671-2022-00264
• Device Sequence Number: 3822643
• Product Code: JWH
• UDI-Device Identifier: 10885862174222
• UDI-Public: 10885862174222
• 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: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2022

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: 02/01/2020
• Device Model Number: LOGIC CR TIB INSERT SLOPE++, SZ 1, 13MM
• Device Catalogue Number: 02-012-49-1013
• 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: 03/01/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2012
• 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: 73 YR
• Patient Sex: Female