MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+,; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-48-1011
Medical Device Problem Codes	Mechanical Problem (1384); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Loss of Range of Motion (2032); Anxiety (2328); Implant Pain (4561)
Date of Event	04/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.
Event or Problem Description
As reported, approximately 2 years post op initial tka, this 61 y/o female patient's left knee was revised.Surgeon performed a poly swap.Cr 1x11 insert swapped out for a crc 1x13 insert.Patient was last known to be in stable condition following the event.Devices are not returning - hospital doesn't release.Photos are attached.
Additional Manufacturer Narrative
H10.Additional information ¿ b5, d8, h6 medical device problem and component after the receipt of additional information corrections have been made to this report and the manufacturer's case.These devices are used for treatment not diagnosis.There is no other information available.Pending investigation.D10.Concomitants: 02-010-03-0210 - logic cr femoral cem, left sz 1-sn (b)(6).02-012-45-1010 - lgc tibial fit tray cem sz 1f / 1t- sn (b)(6).200-03-32 - one peg patella 32mm- sn (b)(6).203-88-11 - (11-2954) ao/sodem 90x25x1.27 sawblade 299206.
Event or Problem Description
It was reported via legal documentation that a patient had a left total knee arthroplasty on (b)(6) 2018 and then approximately 5 years later on (b)(6) 2023 was surgically revised.There is no additional information available/provided.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and loss of range of motion 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 radiographs and relevant clinical information were not provided.H6: corrected health effect, medical device, and investigation clinical codes.

• Brand Name: LOGIC CR TIB INSERT SLOPE+,
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32653 1197
• Manufacturer Contact: geoff gannon ; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16894266
• Report Number: 1038671-2023-00941
• Device Sequence Number: 12305560
• Product Code: JWH
• UDI-Device Identifier: 10885862174185
• UDI-Public: 10885862174185
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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,Followup
• Report Date (Section B): 12/16/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/07/2020
• Device Catalogue Number: 02-012-48-1011
• 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: 04/17/2023
• Supplement Date Received by Manufacturer: 02/01/2024; 12/16/2024
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 05/08/2024; 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2012
• 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.
• Patient Age: 61 YR
• Patient Sex: Female