MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 13MM; SEE H10

Catalog Number	02-012-44-5013
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Adhesion(s) (1695); Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	02/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10.Concomitants: sn (b)(6), cat# 02-010-01-0350 - logic femoral ps cem right sz 5; sn (b)(6), cat#02-012-45-5040 - lgc tibial fit tray cem sz 5f / 4t; sn (b)(6), cat#200-02-35 - three peg patella 35mm.These devices are used for treatment not diagnosis.There is no other information available.Pending investigation.
Event or Problem Description
It was reported via legal documentation that the patient had an initial right total knee arthroplasty on (b)(6) 2016, then approximately 6 years, 4 months later, on (b)(6) 2023 was surgically revised.Revision operative report of (b)(6) 2023 post operative diagnosis: failed right total knee arthroplasty with large osteophytes of the patella.Moderate poly wear of the posterior poly of the poly insert.Significant arthrofibrosis with marked adhesions posteriorly.Revision total knee, extensive sharp debridement, and excision of marked scar tissue.Procedure: severe osteophytes on all 4 sides of patella encased over the patella component.Patella component was removed.Poly was removed, there was moderate posterior wear but no debonding was noted.Surgeon states: ¿i believe most of his problems were related to his arthrofibrosis and scar tissue.¿ the patient was awakened, dressing applied and taken to recovery room per anesthesia.Discharge summary- diagnosis: poly wear of right knee with recalled poly.Procedure: revision of right knee poly and patella.Discharged home to have home physical therapy and home health.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 other information is 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: d6a, 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, loss of range of motion, and/or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user-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, 13MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17755598
• Report Number: 1038671-2023-02277
• Device Sequence Number: 6653983
• Product Code: JWH
• UDI-Device Identifier: 10885862173737
• UDI-Public: 10885862173737
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• 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): 12/12/2024

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: 04/23/2020
• Device Catalogue Number: 02-012-44-5013
• 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: 08/15/2023
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2012
• 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: 61 YR
• Patient Sex: Male