MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 4, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	02-022-44-4013
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10.Concomitants: 6214427 02-020-11-0340 - truliant ps cem fem ps cem right sz 4.6219513 02-022-45-4040 - truliant tib fit tray cem sz 4f / 4t.5617346 200-02-38 - three peg patella 38mm.4988346 201-78-25 - small headed sharp pin, 1 1/8" 4 pack.5921530 201-78-82 - collar fixation pin 2pk 40mm, quick release.5853727 201-78-89 - 3" drill bit, mod.Hex 2 pack.5853749 201-78-89 - 3" drill bit, mod.Hex 2 pack.
Event or Problem Description
As reported via legal documentation, a patient had right total knee replacement on (b)(6) 2019.They underwent revision surgery on 07-dec-2021, approximately 2 years 1 month after their primary procedure due to acute pain, component loosening, and consistent instability.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
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, loosening and/or due to inclusion of the polyethylene in the packaging recall.However, the reported prosthesis wear, instability, and loosening could not be confirmed and potential contributions of user, or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.

• Brand Name: TRULIANT TIB IMP PSC INSERT SZ 4, 13MM
• 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 ct.; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523782617
• MDR Report Key: 17279734
• Report Number: 1038671-2023-01584
• Device Sequence Number: 5184309
• Product Code: JWH
• UDI-Device Identifier: 10885862305305
• UDI-Public: 10885862305305
• 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: 2021
• 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): 10/15/2024

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
• Device Model Number: 02-022-44-4013
• Device Catalogue Number: 02-022-44-4013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown