MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3.5 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC TIBIA PS MOD INSRT SZ 3.5 15MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	01/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately four years post initial tka, this (b)(6) male patient complained of persistent pain associated with total knee.Patient had a revision of total knee.The liner was exchanged.There was no breakage of the device.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Pictures of liner are available.The device is not available for evaluation as they were lost/disposed of during sterilization process.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) as reported, approximately four years post initial tka, this 63 y/o male patient complained of persistent pain associated with a total knee replacement.The patient had a revision; the liner was exchanged.There was no breakage of the device.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Pictures of liner are available.The device is not available for evaluation as they were lost/disposed of during the sterilization process.No additional information is provided.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of surgical revision for pain cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
As a result of additional information received, fields d10 and h6 have been updated.D10: concomitants: 4310845 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f/3.5t.4394501 02-010-01-0235 - logic femoral ps cem left sz 3.5.5034576 200-02-38 - three peg patella 38mm.5396050 204-70-00 - tibial stem ext.Screw.5550056 204-34-04 - fluted stem extension 40l x 14 mm.H3: investigation results - the revision reported may have been the result of polyethylene wear and pain.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, the extent and root cause of the reported polyethylene wear and pain cannot be confirmed as the devices were not available for evaluation.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.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 3.5 15MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 13565340
• Report Number: 1038671-2022-00206
• Device Sequence Number: 5947014
• Product Code: JWH
• UDI-Device Identifier: 10885862001870
• UDI-Public: 10885862001870
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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,Followup
• Report Date (Section B): 01/02/2024

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: 08/21/2020
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 3.5 15MM
• Device Catalogue Number: 02-012-35-3515
• 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: 01/31/2022
• Supplement Date Received by Manufacturer: 08/16/2022; 12/19/2023
• Initial Report FDA Received Date: 02/19/2022
• Supplement Report FDA Received Date: 09/12/2022; 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2012
• 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: 63 YR
• Patient Sex: Male