MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 2.5, 11MM; SEE H10

Model Number	02-012-51-2511
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Emotional Changes (1831); Pain (1994); Synovitis (2094); Osteolysis (2377)
Date of Event	10/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10.Concomitants: 4527785, 02-010-03-0225 - logic cr femoral cem, left sz 2.5.4049641, 02-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 2.5t.4362236, 200-02-35 - three peg patella 35mm.4537197, 204-34-04 - fluted stem extension 40l x 14 mm.4553246, 204-70-00 - tibial stem ext.Screw.Pending investigation.There is no other information available.
Event or Problem Description
It was reported via legal documentation that a patient had a left total knee arthroplasty revision on (b)(6) 2016 and then approximately 6 years later had a surgical revision on (b)(6) 2022.The patient was revised to exactech devices.Revision operative report of (b)(6) 2022 -to revise left tibia and tibial poly; for other mechanical complications of internal left knee prosthesis.Procedure: clear synovial fluid was noted once the joint was entered.The joint had obvious evidence of polyethylene wear debris with diffuse clusters of white synovitis.Delamination on the medial aspect of the tibial polyethylene was immediately noted.A complete synovectomy was accomplished.The femur was inspected and was rigidly fixed with no evidence of loosening.The tibial component was removed and there was extensive osteolysis medially.New devices were fitted and implanted.The patient tolerated the procedure.The patient was awakened and transferred to recovery in good condition after application of a bulky sterile dressing.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.No additional information is available.
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: (b)(6) 02-010-03-0225 - logic cr femoral cem, left sz 2.5.(b)(6) 02-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 2.5t.(b)(6) 200-02-35 - three peg patella 35mm.(b)(6) 204-34-04 - fluted stem extension 40l x 14 mm.(b)(6) 204-70-00 - tibial stem ext.Screw.The following sections were updated: g1, h6.The following sections were corrected: 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 TIB INSERT IMPL CRC, SZ 2.5, 11MM
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 17198686
• Report Number: 1038671-2023-01454
• Device Sequence Number: 17790084
• Product Code: JWH
• UDI-Device Identifier: 10885862230379
• UDI-Public: 10885862230379
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• 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): 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: 02/19/2018
• Device Model Number: 02-012-51-2511
• Device Catalogue Number: 02-012-51-2511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2013
• 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.; SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 104 KG