MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 9MM; SEE H10

Model Number	02-012-44-5009
Medical Device Problem Codes	Mechanical Problem (1384); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had an initial left total knee arthroplasty on (b)(6) 2020 and then approximately 2 years, 4 months later, on 27 oct 2022, they experienced a revision surgery.Revision operative report of 27 oct 2022.Post operative diagnosis- failed left total knee replacement secondary to wear of the bearing surface.Findings: the patient had initially done well, by 2020 the left knee was becoming increasingly swollen, and any increased activity dramatically increased the amount of swelling.He presented in 2022 after the recall was announced.Aspiration of synovial fluid from his knee showed a pattern consistent with accelerated polyethylene wear.Preoperative x-ray showed that the components were well fixed.At surgery they found the typical hypertrophic overgrown synovium with foreign body reaction type appearance.There was severe wear on both medial and lateral polyethylene plateaus.There was some osteolysis under the tibial tray, but the tibial and femoral components were well fixed.Dressings were applied, the patient was awakened and taken to the recovery room in stable condition.There were no complications.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
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitants: (b)(4).02-020-11-0250 - truliant ps cem fem ps cem left sz 5.(b)(4).02-022-45-5050 - truliant tib fit tray cem sz 5f / 5t.(b)(4).200-02-41 - three peg patella 41mm.Pending investigation.There is no other information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, and femoral 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 TIBIA IMPLANT PSC INSERT, SZ 5, 9MM
• 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: kate jacobson
• MDR Report Key: 17107440
• Report Number: 1038671-2023-01318
• Device Sequence Number: 2805611
• Product Code: JWH
• UDI-Device Identifier: 10885862173713
• UDI-Public: 10885862173713
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 12/30/2024

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: 01/29/2021
• Device Model Number: 02-012-44-5009
• Device Catalogue Number: 02-012-44-5009
• 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: 05/10/2023
• Supplement Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2013
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male