MAUDE Adverse Event Report: EXACTECH, INC. KNEE-IMPLANT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	FEMORAL COMPONENTS
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Muscle Weakness/Atrophy (1967); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, the 78 y/o female patient had a knee revision for an unknown reason.Patient was revised to exactech implants.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photos and x-rays.The devices are not available for evaluation due hospital would not allow to obtain devices.
Additional Manufacturer Narrative
Updatedfields: b1, b2 and b5 corrected fields: d4, d6a, d6b, d10, g and g4 h6: corrected clinical codes, medical device problem code and component codes.Added investigation codes d10: 3689807 200-02-29 - three peg patella 29mm 2898672 02-010-03-0220 - logic cr femoral cem, left sz 2 2956763 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t 0y122 203-96-21 - (11-2714) non-exactech 2000 90x13/21x 1.9mm.
Event or Problem Description
It was reported that approximately 101 months after a total knee replacement procedure, the patient has experienced prosthesis wear, pain, stiffness, discomfort and weakness.No further issues or complications were reported.No additional information is available.

• Brand Name: KNEE-IMPLANT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17467144
• Report Number: 1038671-2023-01872
• Device Sequence Number: 8901832
• Product Code: JWH
• UDI-Device Identifier: 10885862174321
• UDI-Public: 10885862174321
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

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 Expiration Date: 07/28/2019
• Device Model Number: FEMORAL COMPONENTS
• Device Catalogue Number: 02-012-49-2011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2023
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2011
• 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 Age: 78 YR
• Patient Sex: Female