MAUDE Adverse Event Report: ORTHO DEVELOPMENT BALANCED KNEE SYSTEM; TOTAL KNEE PROSTHESIS

Model Number	561-0510
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, patient had received a full sleeve revision knee construct.On (b)(6) 2020, patient's construct was revised when the patient had presented with pain and a possible infected knee.Upon opening, the surgeon found metallosis and noted that the femoral component could move in the anterior/posterior direction with relation to the junction box.

• Brand Name: BALANCED KNEE SYSTEM
• Common Device Name: TOTAL KNEE PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper, ut
• MDR Report Key: 10189291
• Report Number: 1722511-2020-00014
• Device Sequence Number: 835502
• Product Code: JWH
• UDI-Device Identifier: 00822409037827
• UDI-Public: (01)00822409037827(17)260107(10)A207839
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2020

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: 01/07/2026
• Device Model Number: 561-0510
• Device Lot Number: A207839
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 06/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR