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

Model Number	162-1400A
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial report did not indicate an issue with the tibial tray.In general, there are multiple factors related to the procedure that could routinely increase the difficulty of attaching the insert to the tibial tray.This report is based on new information received on (b)(6) 2019 when the investigation revealed an out of tolerance chamfer inside the tibial tray that may make it more difficult to snap the insert in place.The initial reporter indicated there were 3 events related to difficulty in assembling.This is report 2 of 3.
Event or Problem Description
During total knee arthroplasty on (b)(6) 2019, the surgeon had difficulty assembling the insert to the tibial tray.The initial reporter indicated there were 3 events related to difficulty in assembling.This is report 2 of 3.

• 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: 8697691
• Report Number: 1722511-2019-00016
• Device Sequence Number: 19498963
• Product Code: JWH
• UDI-Device Identifier: 00822409010158
• UDI-Public: (01)00822409010158(17)231109(10)A204324
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K994370
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/13/2019

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: 11/09/2023
• Device Model Number: 162-1400A
• Device Lot Number: A204324
• 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: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1