MAUDE Adverse Event Report: EXACTECH, INC. KNEE COMPONENT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-44-5011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	09/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a left/right total knee arthroplasty on (b)(6) 2017 and then experienced a revision surgical procedure on (b)(6) 2021 approximately 3 years and 11 months after initial implant.There is no device information provided.No other patient information/medical history reported.No images of the devices are provided.The device will not be returned.There is no other information available.
Additional Manufacturer Narrative
H10: pending investigation.These devices are used for treatments, not diagnosis.There is no other information available.
Additional Manufacturer Narrative
D4: added catalog number, expiration date, serial number, and udi.D10: (b)(6), 02-010-01-0250 - logic femoral ps cem left sz 5; (b)(6), 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t; (b)(6), 200-02-38 - three peg patella 38mm.Manufacturer narrative updated: the reason for the reported event cannot be confirmed from the information provided but may be due to prosthesis wear, and/or related to inclusion of the polyethylene in the packaging recall.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: KNEE COMPONENT
• 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 FL 32653
• Manufacturer Contact: matt collins
• MDR Report Key: 19229151
• Report Number: 1038671-2024-01026
• Device Sequence Number: 5919448
• Product Code: JWH
• UDI-Device Identifier: 10885862173720
• UDI-Public: 10885862173720
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• 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): 09/24/2024

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 Expiration Date: 01/06/2025
• Device Catalogue Number: 02-012-44-5011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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