MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-47-4009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Implant Pain (4561)
Date of Event	10/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a right total knee arthroplasty on (b)(6) 2013, and then experienced a revision surgical procedure on (b)(6) 2023, approximately 10 years after initial implant.Revision operative report of (b)(6) 2023 ¿ postoperative diagnosis: failure of right total knee arthroplasty due to failure of tibial polyethylene and patellar button.Revision of tibial and patellar components.Patient revised to exactech devices.Patient tolerated the procedure well and was transferred to the recovery room in stable condition.The devices were not returned, there are no images provided.There is no other information available.
Additional Manufacturer Narrative
H10.D.4 there were 2 devices listed in the invoice for this patient- it is unknown which device was implanted- product information: 2232562 02-012-47-4009 - logic cr tib insert std, sz 4, 9mm manufacture date: 30-jan-2012; exp.Date: 27-jan-2020; 2538397.02-012-47-4009 - logic cr tib insert std, sz 4, 9mm manufacture date: 30-nov-2012; exp.Date: 28-nov-2020; d10.Concomitants - product information: 2784416 02-010-03-0340 - logic cr femoral cem, right, sz 4; 2789048 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t; 2792022 200-03-35 - one peg patella 35mm.Pending investigation.There is no other information available.
Additional Manufacturer Narrative
1038671-2024-04831 this follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g1, h6.The following sections were corrected: b1, b2, g1, h6.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-04831.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and patellar loosening or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 4, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 18812765
• Report Number: 1038671-2024-00355
• Device Sequence Number: 4512416
• Product Code: JWH
• UDI-Device Identifier: 10885862174444
• UDI-Public: 10885862174444
• 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: 2013
• 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
• Report Date (Section B): 12/13/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 02-012-47-4009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 12/13/2024
• 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: 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: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male