MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 5 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	02-022-35-5011
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation, this patient had knee implantation date of (b)(6) 2019.They had revision surgery (b)(6) 2023, approximately 3 years 3 months after their initial procedure.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.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: serial #: (b)(6), category #: 200-07-35 - advanced patella 35mm 3 peg implant.Serial #: (b)(6), category #: 02-022-45-5040 - truliant tib fit tray cem sz 5f / 4t.Serial #: (b)(6), category #: 02-020-11-0250 - truliant ps cem fem ps cem left sz 5.Serial #: (b)(6), category #: 521-78-36 - threaded pin size 5.1 collarless 2pk.
Additional Manufacturer Narrative
Upon investigation, it has been discovered that this complaint is a duplicate and all information has been appropriately reported in mfr #1038671-2023-00469.This case will be closed and all information will be compliantly processed and will be reported under mfr# 1038671-2023-00469.These devices are used for treatment, not diagnosis.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 5 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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 ; 3523782617
• MDR Report Key: 16860109
• Report Number: 1038671-2023-00888
• Device Sequence Number: 5460359
• Product Code: JWH
• UDI-Device Identifier: 10885862304636
• UDI-Public: 10885862304636
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 05/17/2023

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
• Device Model Number: 02-022-35-5011
• Device Catalogue Number: 02-022-35-5011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2019
• 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-0023-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male