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

Model Number	02-012-49-4009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	12/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 2865700 02-010-03-0340 - logic cr femoral cem, right, sz 4.3650363 02-012-41-4040 - logic tibia traptray cem sz 4f/4t.3651211 200-02-38 - three peg patella 38mm.Pending investigation.
Event or Problem Description
As reported via legal documentation a 68 y/o female patient had a right knee replacement on (b)(6) 2014.Approximately 8 years and 4 months after the initial procedure the patient had a right knee revision on (b)(6) 2022 due to pain and swelling.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.Revision op report.10 may 2023/ k mcguinness received via legal 18 apr 2023.Diagnosis: failed right knee arthroplasty secondary to poly wear.During the procedure there was extensive synovitic changes but no evidence of metalosis.An extensive and meticulous synovectomy was performed.The posterior portion of poly was thinned but not fractured.Sterile dressing was applied.The patient was brought to recovery in stable condition.
Additional Manufacturer Narrative
Recall number: z-0021-2022 this follow-up report is being submitted to relay additional and/or corrected information.The product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.D10: concomitants: 2865700 02-010-03-0340 - logic cr femoral cem, right, sz 4, 3650363 02-012-41-4040 - logic tibia traptray cem sz 4f/4t, 3651211 200-02-38 - three peg patella 38mm.The following sections were updated: g1, h6, the following sections were corrected: b1, b2, g1, h6.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.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 SLOPE++, SZ 4, 9MM
• 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 ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16909857
• Report Number: 1038671-2023-00963
• Device Sequence Number: 7206158
• Product Code: JWH
• UDI-Device Identifier: 10885862174512
• UDI-Public: 10885862174512
• 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: 2014
• Device Explanted Year: 2022
• 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): 12/31/2024

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 Expiration Date: 05/09/2021
• Device Model Number: 02-012-49-4009
• Device Catalogue Number: 02-012-49-4009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• 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; SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female