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

Model Number	162-1300A
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was revised due to subsidence of the tibial tray.The implant was discarded and not returned.

• 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: 8561178
• Report Number: 1722511-2019-00006
• Device Sequence Number: 2294244
• Product Code: JWH
• UDI-Device Identifier: 00822409010141
• UDI-Public: (01)00822409010141(17)220721(10)A180909
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K994370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2019

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: 07/21/2022
• Device Model Number: 162-1300A
• Device Lot Number: A180909
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR