MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 3, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-51-3011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 45 months after a left total knee replacement procedure, the patient has experienced unknown issues.The device was not returned for evaluation.No photographs or x-rays were provided for review; therefore the reported event cannot be confirmed through analysis.No operative notes were provided; therefore, a review of device usage and technique could not be performed.No information concerning patient conditions, co-morbidities, or other health or anatomical concerns was provided and it is therefore unknown if patient-related factors may have caused or contributed to the reported event.No further issues or complications were reported.No additional information is available.The cause of the reported event cannot be determined based on the information made available.Should additional, relevant information become available, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
D10 concomitant devices: (b)(6), 204-70-00 - tibial stem ext.Screw, (b)(6), 02-020-13-0330 - truliant cr cem fem cr cem right sz 3, (b)(6), 00-02-35 - three peg patella 35mm, (b)(6), 02-012-60-1425 - tru stem ext 14mm x 25mm, (b)(6), 02-022-45-3030 - truliant tib fit tray cem sz 3f / 3t, (b)(6), 201-78-98 - 2 pk, schanz pin, 4mm x 130mm, (b)(6), 201-78-15 - holding pin mini sharp point 4 pk.Concomitant devices: (b)(6), 204-70-00 - tibial stem ext.Screw, (b)(6), 02-020-13-0330 - truliant cr cem fem cr cem right sz 3, (b)(6), 00-02-35 - three peg patella 35mm, (b)(6), 02-012-60-1425 - tru stem ext 14mm x 25mm, (b)(6), 02-022-45-3030 - truliant tib fit tray cem sz 3f / 3t, (b)(6), 201-78-98 - 2 pk, schanz pin, 4mm x 130mm, (b)(6), 201-78-15 - holding pin mini sharp point 4 pk.The product associated with the reported event is within the scope of recall however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.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.
Additional Manufacturer Narrative
"this follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6.The following sections were corrected: h6.Mdr section codes updated/corrected: b.The reason for the reported event cannot be confirmed from the information provided but may be due to prosthesis wear and/or inclusion of the polyethylene in the packaging recall.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.There were no updates to this case.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT TIB IMP CRC INSERT SZ 3, 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 court; gainesville 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 19816763
• Report Number: 1038671-2024-02499
• Device Sequence Number: 18313757
• Product Code: JWH
• UDI-Device Identifier: 10885862307644
• UDI-Public: 10885862307644
• 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: 2020
• 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): 12/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02-022-51-3011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2019
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Female