MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 4 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-4011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Scar Tissue (2060); Synovitis (2094); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	08/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: (b)(6) 02-010-06-0240 - tru cc femoral size 4 left.(b)(6) 02-012-60-1880 - tru stem ext 18mm x 80mm.(b)(6) 208-05-04 - cc distal fem augment sz 4, 5mm (b)(6) 208-05-04 - cc distal fem augment sz 4, 5mm.(b)(6) 200-02-38 - three peg patella 38mm.(b)(6) 204-70-00 - tibial stem ext.Screw.(b)(6) a10012 - gps implant kit v2.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
Legal case ¿ usa (mdl no.3044).(b)(4) lk rev related.It was reported that approximately 19 months after a left total knee replacement procedure, the patient has experienced prosthesis wear, suffered and continues to suffer permanent and debilitating injuries and damages, including but not limited to severe pain, significant scarring, swelling, effusion, inflammation, knee popping/clucking, knee giving away, difficulty walking, antalgic gait and other injuries presently undiagnosed.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
H6: corrected the following: health effect - clinical code, type of investigation manufacturer narrative updated: the reason for the reported event cannot be confirmed from the information provided, but may have been due to prosthesis wear.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.Additionally, this device was packaged after initiation of the recall and was not packaged in a non-conforming vacuum bag.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 4 11MM
• 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
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 19943633
• Report Number: 1038671-2024-02748
• Device Sequence Number: 4876426
• Product Code: JWH
• UDI-Device Identifier: 10885862304452
• UDI-Public: 10885862304452
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02-022-35-4011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown