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

Model Number	563-1512
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, the surgeon performed a revision of a right total knee arthroplasty.On (b)(6) 2018, the patient dislocated the knee and the surgeon performed an open reduction and poly swap from 12mm to 14mm.The surgeon noted that the posterior locking mechanism for the poly insert had been damaged.
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.Review of similar complaints found that when an insert appears to be dislodged after a short time in-vivo, it is likely due to installation issues at the time of the index surgery.

• Brand Name: BALANCED KNEE SYSTEM
• Common Device Name: KNEE PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• MDR Report Key: 7816293
• Report Number: 1722511-2018-00030
• Device Sequence Number: 11084448
• Product Code: JWH
• UDI-Device Identifier: 00822409004669
• UDI-Public: (01)00822409004669(17)190504(10)A175834
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K994370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2018

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: 05/04/2019
• Device Model Number: 563-1512
• Device Lot Number: A175834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR