MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+, SZ 5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Catalog Number	02-012-48-5011
Medical Device Problem Codes	Fracture (1260); Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Pain (1994); Synovitis (2094); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Joint Laxity (4526); Joint effusion (4849)
Date of Event	11/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported by legal notification, the patient had an initial left tka o (b)(6) 2016.Due to worsening pain and instability the patient underwent revision surgery on (b)(6) 2022.During the revision surgery, the surgeon identified "large effusion and very hypertrophic synovium.When removing the synovium you could visualize plastic debris within the synovium and the synovium was fibrillated." the surgeon also noted "there was certain degradation and destruction of the posterior lip and the medial and lateral compartments with pitting and delamination and fracture." upon information and belief, the loose components and significant synovitis were due to premature polyethylene wear of the tibial insert.
Event or Problem Description
Additional information - left total knee arthroplasty revision for poly swap.Approximately 6 years after implant.Patient was last known to be in stable condition following the event.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return, hospital retained.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
D10.Concomitants- (b)(6) 02-010-03-0250 - logic cr femoral cem, left, sz 5; (b)(6) 02-012-45-5040 - lgc tibial fit tray cem sz 5f / 4t; (b)(6) 200-02-35 - three peg patella 35mm.H6.Investigation results - the revision reported may have been the result of pain, instability and prosthesis wear/fracture as stated in the legal documentation and operative notes.The wear/fracture may have been the result of a combination of overall posterior slope of the tibial insert and/or patient related conditions, which allowed for excessive posterior contact, and led to wear and fracture of the polyethylene.However, this cannot be confirmed because the revised component was not available for evaluation and images of the explanted device or pre-revision radiographs were not provided.Additionally, a contributing factor to the wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.These devices are used for treatment not diagnosis.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/g4, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: a, b, c, 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 fracture or due to inclusion of the polyethylene in the packaging recall.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.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 5, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16406238
• Report Number: 1038671-2023-00189
• Device Sequence Number: 6279302
• Product Code: JWH
• UDI-Device Identifier: 10885862174598
• UDI-Public: 10885862174598
• 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: 2016
• 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,Followup
• Report Date (Section B): 02/03/2025

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: 06/17/2019
• Device Catalogue Number: 02-012-48-5011
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/31/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 07/12/2023; 01/31/2025
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 08/16/2023; 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2011
• 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: 63 YR
• Patient Sex: Male