MAUDE Adverse Event Report: EXACTECH, INC. TRU CC TIB INSERT SIZE 4, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-65-4013
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	12/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10.Pending investigation.
Event or Problem Description
It is reported via legal documentation that a patient had a left total knee arthroplasty on (b)(6) 2018, with no revision surgery reported.There is no device information provided.No radiographic images of the device are provided.There is no other information available.
Additional Manufacturer Narrative
B3 this follow-up report is being submitted to relay additional and/or corrected information.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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
D10 concomitants: (b)(6) 02-010-06-0240 - tru cc femoral size 4 left.(b)(6) 02-010-66-3001 - metaphyseal femoral cone, large, h32mm.(b)(6) 02-012-60-2080 - tru stem ext 20mm x 80mm.(b)(6) 200-02-41 - three peg patella 41mm.(b)(6) 208-05-04 - cc distal fem augment sz 4, 5mm.(b)(6) 208-05-04 - cc distal fem augment sz 4, 5mm.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.D.Updated suspect medical device added product information.H6: corrected the following: health effect - clinical code, impact code, component code, type of investigation, investigation findings, investigation conclusions.

• Brand Name: TRU CC TIB INSERT SIZE 4, 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: matt collins
• MDR Report Key: 19068871
• Report Number: 1038671-2024-00760
• Device Sequence Number: 20574569
• Product Code: JWH
• UDI-Device Identifier: 10885862613493
• UDI-Public: 10885862613493
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 02-012-65-4013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 10/01/2024; Not provided
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 10/23/2024; 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2016
• 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: Required Intervention
• Patient Sex: Unknown