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

Model Number	164-5035
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A total knee was performed on a patient on (b)(6) 2017.The patient reported pain and the knee was revised on (b)(6) 2018.Upon exposure, the patella was no longer attached to the host bone.
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 mode of failure.A visual examination revealed that the bone cement mantle separated progressively over time from the host bone.Simultaneously, the patella pegs were over-stressed which led to their fatigue failure.It also appears that the pegs fractured successively.The root cause cannot be definitively identified from the available evidence.Possible contributors include inadequate cementing technique and inadvertent incorporation of a foreign substance in the cement mantle.

• Brand Name: BALANCED KNEE SYSTEM
• Common Device Name: TOTAL KNEE REPLACEMENT PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• MDR Report Key: 7638478
• Report Number: 1722511-2018-00025
• Device Sequence Number: 2244685
• Product Code: JWH
• UDI-Device Identifier: 00822409006755
• UDI-Public: (01)00822409006755(17)231006(10)A170789
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K131337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

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: 10/06/2023
• Device Model Number: 164-5035
• Device Lot Number: A170789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/05/2018
• Supplement Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 01/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR