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

Model Number	LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 9 MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the 55 y/o female patient presented to the surgeon's office with complaints of pain, swelling, and stiffness in their right knee.The patient had a previous right primary tka done on (b)(6) 2015.An examination was done and x-rays were performed and reviewed.The original poly implant was searched in the recall database and did come back as an affected poly in the recall.The patient was scheduled for a right knee revision possible poly swap.Then, the revision surgery was performed on (b)(6) 2022.The surgeon opened the knee joint, performed a synovectomy, and removed scar tissue.The surgeon then examined the implants, noting that the patella had been worn.An osteotome and poly removal tool was used to remove the poly implant.The implant showed to be broken and in pieces posteriorly.It showed delamination and pitting.The poly remnants were removed from the knee joint and the knee was irrigated well.Then attention was given to the metal femur and tibia implants, the surgeon used a tamp/ dis-impactor tool to check the metal implants and they showed to be loose.The surgeon then removed all of the implants within the right knee, femur, tibia, and patella.The surgeon then performed a revision knee arthroplasty using a competitor's device.The patient was last known to have left the operating room (or) stable.Photos and x-rays received.The device is available for evaluation.
Additional Manufacturer Narrative
Concomitant products: - lgc tibial fit tray cem sz 3.5f / 3.5t (cat# 02-012-45-3535 / serial# (b)(4).- logic cr femoral cem, right, sz 3.5 (cat# 02-010-03-0335 / 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 and h6 have been updated accordingly.(h3) the revision reported was likely the result of a combination of high in-vivo forces and instability of the knee that allowed for excessive posterior and medial contact leading to full-thickness wear of the polyethylene tibial insert and subsequent wear of the tibial tray.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 for the event of ¿loosening¿ is associated with weakened integration of the device at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.

• Brand Name: LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 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: 15694787
• Report Number: 1038671-2022-01370
• Device Sequence Number: 12438981
• Product Code: JWH
• UDI-Device Identifier: 10885862159311
• UDI-Public: 10885862159311
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

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: 08/10/2019
• Device Model Number: LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 9 MM
• Device Catalogue Number: 02-012-49-3509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2022
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 10/29/2022
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2011
• 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
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 101 KG