MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 1.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC FEMORAL PS CEM RIGHT SZ 1.5
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, a (b)(6) female patient¿s reason for surgery was the failure of the implants.Surgeon thought the surgery was just going to be a poly exchange, however once the knee was opened up, it was discovered the femur was loose as well and that there was significant bone lose.It was revised to a size cc femur, 4mm offset, 10x120 stem, 10 and 5 post aug block, two 5 distal aug blocks and a 1.5 10mm psc poly, the tibial tray was not touched as it was well fixed.Patient was last known to be in stable condition following the event.The device will be return.
Additional Manufacturer Narrative
Concomitant medical products: truliant tib imp ps insert sz 1.5, 9mm (cat# 02-012-35-1509 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Concomitant medical products: truliant tib imp ps insert sz 1.5, 9mm (cat# 02-012-35-1509 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, a (b)(6) female patient¿s reason for surgery was the failure of the implants.Surgeon thought the surgery was just going to be a poly exchange, however once the knee was opened up, it was discovered the femur was loose as well and that there was significant bone lose.It was revised to a size cc femur, 4mm offset, 10x120 stem, 10 and 5 post aug block, two 5 distal aug blocks and a 1.5 10mm psc poly, the tibial tray was not touched as it was well fixed.Patient was last known to be in stable condition following the event.The device will be return.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h1, h2, h3 and h6 have been updated accordingly.The revision reported was likely the result of both aseptic (non-infected) femoral loosening and prosthesis wear.The femoral loosening was likely the result of both patient-related conditions and an insufficient bond between the femoral component and the bone.The prosthesis wear was likely the result of axial rotation mismatch of the femoral component relative to the tibial insert and third body wear.Additionally, a contributing factor to the wear and delamination may have been the result of being packaged in a non-conforming vacuum bag for more than five years.The most probable root cause associated with the reported event of "loosening - femoral¿ is associated with weakened integration of the femoral component at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.Furthermore, 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 via legal documentation, this patient had right knee replacement on (b)(6)2017 due to osteoarthritis.The patient underwent left knee revision surgery on (b)(6)2021, approximately 4 years 1 month after their primary surgery.(b)(6) 2021 op report found clear, straw-colored joint fluid that yielded trace leukocyte esterase and a low number of nucleated cells on cell count, extensive polyethylene and/or cement synovitis, mild lateral patellar facet wear, no patellar loosening, gross femoral loosening due to debonding, distal femoral osteolysis, a well-fixed tibial implant with minimal posterior medial tibial osteolysis, and pitting and delamination of the medial patellar insert on the topside.The patient was transferred to the recovery room in stable condition.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Based on the receipt of additional information, the following fields have been updated: b5, d6a, d8, h7, and h9.Further updates and/or re-opened investigation results will be reported within 30 days of their receipt.

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 1.5
• 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: 13081381
• Report Number: 1038671-2021-00733
• Device Sequence Number: 19321688
• Product Code: JWH
• UDI-Device Identifier: 10885862175854
• UDI-Public: 10885862175854
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/05/2021
• Device Model Number: LOGIC FEMORAL PS CEM RIGHT SZ 1.5
• Device Catalogue Number: 02-010-01-0315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2021
• Supplement Date Received by Manufacturer: 04/22/2022; 05/05/2023
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 05/25/2022; 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2016
• 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: 62 YR
• Patient Sex: Female