MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 2.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC FEMORAL PS CEM RIGHT SZ 2.5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	10/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: logic tibia ps mod insrt sz 2 11mm (cat# 02-012-35-2011 / (b)(4)).Lgc tibial fit tray cem sz 2f / 2t (cat# 02-012-45-2020 / serial# (b)(4)).Three peg patella 32mm (cat# 200-02-32 / serial# (b)(4)).Fluted stem extension 25l x 14 mm (cat# 204-34-02 / serial# (b)(4)).Tibial stem ext.Screw (cat# 204-70-00 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately four years post left side tka, this (b)(6) y/o female patient had a revision due to osteolysis.
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of osteolysis possibly related to wear of the tibial insert, which allowed for the femoral component and tibial tray to loosen from the bone.However, this cannot be confirmed because wear of the tibial insert was not reported, no images of the revised components were provided, and the devices were not returned to exactech 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.Furthermore, the most probable root cause associated with the event of "loosening¿ is associated with destruction or disappearance of bone tissue likely related to weakened integration of an implant at the bone-implant interface.Section d1: brand name section d4: model number, catalog number, serial number, expiration date, unique identifier (udi)#.Section d10: concomitant medical products.Section h4: device manufacture date.Section d10: concomitant medical products: logic tibia ps mod insrt sz 2.5 9mm (cat#: 02-012-35-2509 / 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).

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 2.5
• 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: 13485365
• Report Number: 1038671-2022-00187
• Device Sequence Number: 5348849
• Product Code: JWH
• UDI-Device Identifier: 10885862001221
• UDI-Public: 10885862001221
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/04/2020
• Device Model Number: LOGIC FEMORAL PS CEM RIGHT SZ 2.5
• Device Catalogue Number: 02-010-01-0325
• 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: 01/19/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2015
• 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 Age: 54 YR
• Patient Sex: Female