MAUDE Adverse Event Report: EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM
Medical Device Problem Codes	Corroded (1131); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Insufficient Information (4580)
Date of Event	11/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a left knee replacement on (b)(6) 2017.Approximately 5 years and 8 months after the initial procedure the patient had a left knee revision on (b)(6) 2022.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
H3: investigation results - the prosthesis wear reported may have been the result of malalignment between the implants, high contact stresses, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, the extent and root cause of the reported polyethylene wear cannot be confirmed as the devices were not available for evaluation and neither radiographs, photographs or operative notes were provided.
Additional Manufacturer Narrative
The following sections have corrected information: (b5) per legal notification, the patient was required to undergo revision surgery due to severe, pain, swelling, and instability due to wear of the polyethylene components and resulting component loosening and/or other failure failures causing serious complications including tissue damage, osteolysis, permanent bone loss, and other injuries.The patient's previous anterior midline incision was utilized.Medial arthrotomy quad split was performed.Cultures were sent and returned as negative for acute inflammation.The knee was the assessed for varus valgus stability and was noted to have slight mismatch.The femoral and tibial components appeared to be stable.The poly insert was removed.The poly insert was an 11 mm poly.There was clear evidence of oxidation on the poly.Following balancing the knee, the knee was once again trialed and was determined that a 12 mm insert was appropriate with regard to varus and valgus stability in both flexion and extension.Attention was turned toward closure.The final 12 mm cruciate retaining constrained liner from exactech was then secured in place.The knee was once again assessed for stability and range of motion and was determined to be satisfactory.The patella tracked midline.Attention was then turned toward closure.
Event or Problem Description
Per legal notification, the patient was required to undergo revision surgery due to severe, pain, swelling, and instability due to wear of the polyethylene components and resulting component loosening and/or other failure failures causing serious complications including tissue damage, osteolysis, permanent bone loss, and other injuries.The patient's previous anterior midline incision was utilized.Medial arthrotomy quad split was performed.Cultures were sent and returned as negative for acute inflammation.The knee was the assessed for varus valgus stability and was noted to have slight mismatch.The femoral and tibial components appeared to be stable.The poly insert was removed.The poly insert was an 11 mm poly.There was clear evidence of oxidation on the poly.Following balancing the knee, the knee was once again trailed and was determined that a 12 mm insert was appropriate with regard to varus and valgus stability in both flexion and extension.Attention was turned toward closure.The final 12 mm cruciate retaining constrained liner from exactech was then secured in place.The knee was once again assessed for stability and range of motion and was determined to be satisfactory.The patella tracked midline.Attention was then turned toward closure.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.D4: corrected.D10: concomitant devices.(b)(6) 02-010-03-0240 - logic cr femoral cem, left, sz 4.(b)(6) 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t.(b)(6) 200-02-38 - three peg patella 38mm.G4: corrected.

• Brand Name: SPECIFIC DEVICE NOT REPORTED
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; gainesville 32653 ; 3523771140
• MDR Report Key: 17470357
• Report Number: 1038671-2023-01879
• Device Sequence Number: 20323964
• Product Code: JWH
• UDI-Device Identifier: 10885862174529
• UDI-Public: 10885862174529
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/13/2025

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: 12/13/2020
• Device Model Number: LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM
• Device Catalogue Number: 02-012-49-4011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 02/07/2024; 09/25/2024; Not provided
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 02/08/2024; 10/16/2024; 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown