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

Model Number	163-1509
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	02/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record notes no material nonconformance's, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions nor labeling that may have caused or contributed to this mode of failure.
Event or Problem Description
A patient directly contacted our company and reported that his insert "sticks out" when he bends.We referred him to his surgeon for consultation.He indicated that he had already contacted his surgeon who took x-rays and determined that nothing was wrong with the implants but asked him to come in for more testing.Subsequent to this call, it was reported that the patient is scheduled for a revision surgery due to a loose insert.

• Brand Name: BALANCED KNEE SYSTEM
• Common Device Name: TOTAL KNEE PROSTHESIS SYSTEM
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• MDR Report Key: 7351204
• Report Number: 1722511-2018-00005
• Device Sequence Number: 62006
• Product Code: JWH
• UDI-Device Identifier: 00822409009008
• UDI-Public: (01)00822409009008(17)171011(10)A157507
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K994370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/19/2018

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 Expiration Date: 10/11/2017
• Device Model Number: 163-1509
• Device Lot Number: A157507
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 03/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR