MAUDE Adverse Event Report: ORTHO DEVELOPMENT BALANCED KNEE SYSTEM UC TIBIAL INSERT; TOTAL KNEE REPLACEMENT PROSTHESIS

Model Number	166-7407
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Limited Mobility Of The Implanted Joint (2671)
Date of Event	06/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the frail condition of the patient, the doctor has decided to monitor the progress of the patient.
Event or Problem Description
A total knee replacement surgery was performed in which an uc (ultra congruent) tibial insert was implanted with a ps (posterior stabilized) femoral component which is not indicated as a compatible combination.

• Brand Name: BALANCED KNEE SYSTEM UC TIBIAL INSERT
• Common Device Name: TOTAL KNEE REPLACEMENT PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• MDR Report Key: 6713052
• Report Number: 1722511-2017-00004
• Device Sequence Number: 11205408
• Product Code: JWH
• UDI-Device Identifier: 00822409032549
• UDI-Public: (01)00822409032549(17)240504(10)A178135
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K090705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/20/2017

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: 05/04/2024
• Device Model Number: 166-7407
• Device Lot Number: A178135
• 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: 06/20/2017
• Initial Report FDA Received Date: 07/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR