MAUDE Adverse Event Report: EXACTECH, INC. LOGIC PS TIB INS SZ 3.5 17MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC PS TIB INS SZ 3.5 17MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 4 mos.Postop the last ltka, this (b)(6) y/o male patient was complaining of pain and instability.Patient¿s ltka had been revised once before in 2017.Patient was revised to sz 3.5, 17mm psc.Patient was last known to be in stable condition following the event.The device will not be returned for evaluation due to hospital policy.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.As reported, approximately 4 mos.Postop the last ltka, this 62 y/o male patient was complaining of pain and instability.Patient¿s ltka had been revised once before in 2017.Patient was revised to sz 3.5, 17mm psc.Patient was last known to be in stable condition following the event.The device will not be returned for evaluation due to hospital policy.Upon review of all available information, there is no evidence to suggest that a design or manufacturing issue caused or contributed to this event.The reported revision was likely the result of underlying patient factors, which led to instability of the joint.
Additional Manufacturer Narrative
D10.Concomitants: 4310966 200-02-41 - three peg patella 41mmas.H3: investigation results - the revision reported was likely the result of prosthesis wear.Contributing factors to the reported wear could include the reported joint laxity, patient-related conditions, and/or it may have been the result of being packaged in a non-conforming vacuum bag for more than five years.The extent and root cause of the prosthesis wear could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.

• Brand Name: LOGIC PS TIB INS SZ 3.5 17MM
• 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: 12619047
• Report Number: 1038671-2021-00531
• Device Sequence Number: 13790657
• Product Code: JWH
• UDI-Device Identifier: 10885862247391
• UDI-Public: 10885862247391
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• 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): 12/21/2023

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: 10/22/2021
• Device Model Number: LOGIC PS TIB INS SZ 3.5 17MM
• Device Catalogue Number: 02-012-35-3517
• 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: 09/23/2021
• Supplement Date Received by Manufacturer: 04/26/2022; 12/04/2023
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 05/26/2022; 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2013
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male