MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE +, SZ 2.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	02-012-48-2509
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation, this patient had an initial knee arthroplasty was performed on (b)(6) 2019.As a result of the premature polyethylene failure, they underwent a revision total knee arthroplasty on (b)(6) 2023, approximately 3 years 8 months after their initial surgery.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
Pending investigation.D10.Concomitants: serial #: (b)(4), category #: 02-010-03-0225 - logic cr femoral cem, left sz 2.5, serial #: (b)(4), category #: 200-02-32 - three peg patella 32mm, serial #: (b)(4), category #: 02-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 2.5t.
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
It was reported via legal documentation-the patient was revised to non exactech devices.Revision operative report of (b)(6) 2023-postoperative diagnosis: left total knee arthroplasty with polyethylene failure and resultant osteolysis.Revised both components, with associated synovectomy.Indications- patient presented with pain and effusions.X-ray and ct scan revealed some osteolysis.Esr and crp were negative for infection.Revision for osteolysis from polyethylene failure.Procedure: large effusion with hypertrophic synovium.No metallosis, no purulence within the joint.The polyethylene showed completed destruction of the posterior lip and pitting and delamination throughout the prosthetic.Tibial tray and femoral components were removed with all associated cement.The patella polyethylene was inspected, it appeared preserved, so it was left in situ.New devices were trialed and then implanted.The patient was awakened, taken to the recovery room in stable condition, no complications throughout case.No other information is available.
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.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.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.H6: corrected health effect, component, and investigation clinical codes.

• Brand Name: LOGIC CR TIB INSERT SLOPE +, SZ 2.5, 9 MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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, FL 32653 ; 3523782617
• MDR Report Key: 16838800
• Report Number: 1038671-2023-00858
• Device Sequence Number: 6823883
• Product Code: JWH
• UDI-Device Identifier: 10885862159182
• UDI-Public: 10885862159182
• 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: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2024

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
• Device Expiration Date: 08/15/2019
• Device Model Number: 02-012-48-2509
• Device Catalogue Number: 02-012-48-2509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 09/08/2023; 12/16/2024
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 10/31/2023; 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2011
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female