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

Model Number	166-5207
Medical Device Problem Code	Misassembled During Installation (4049)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During total knee arthroplasty, the surgeon reported that the insert was not fully seated onto the tibial tray by 1 to 2 mm.The surgeon performed extension and bending movement, judged that there was no problem with stability, and then ended the operation.

• Brand Name: BALANCED KNEE SYSTEM
• Common Device Name: TOTAL KNEE PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• MDR Report Key: 8708275
• Report Number: 1722511-2019-00018
• Device Sequence Number: 13951252
• Product Code: JWH
• UDI-Device Identifier: 00822409006892
• UDI-Public: (01)00822409006892(17)250330(10)A192244
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/18/2019

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: 03/30/2025
• Device Model Number: 166-5207
• Device Lot Number: A192244
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR