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

Model Number	166-5307
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Arthritis (1723)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during total knee arthroplasty, the insert had some "float" after it was inserted.The surgeon removed it and applied it again multiple times but with the same result.A second insert was obtained and applied but "float" was still present.It was removed and reinserted 2 more times.Upon the 3rd insertion, the surgeon said it fit and completed the normal stretching and flexing exercises to confirm stability before closing.Subsequently, the local representative examined the first insert and noted deformation in the poly.This report is filed because the local representative reported that the second insert was not locked.
Additional Manufacturer Narrative
A review of the device history record notes no material nonconformances, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions nor labeling that may have caused or contributed to this type of event.It is possible that the 2nd insert was not fully engaged upon completion of the surgery however the surgeon felt that the insert was adequately assembled.Assembling the tibial insert to the tibial tray is a known issue in total knee arthroplasty and surgeons can typically correct any issues to implant a fully assembled tibial insert.

• Brand Name: BALANCED KNEE SYSTEM
• Common Device Name: TOTAL KNEE PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper, ut
• MDR Report Key: 10189917
• Report Number: 1722511-2020-00015
• Device Sequence Number: 835503
• Product Code: JWH
• UDI-Device Identifier: 00822409007004
• UDI-Public: (01)00822409007004(17)260228)(10)A211164
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2020

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: 02/28/2026
• Device Model Number: 166-5307
• Device Lot Number: A211164
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR