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

Model Number 561-0010

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Unspecified Musculoskeletal problem (4535)

Event Date 12/13/2021

Event Type  Injury  

Manufacturer Narrative

The following information is not available due to the device was not returned, and the original surgery cannot be identified: lot, implant date, and device manufacture date.

Event Description

On (b)(6) 2021, a femoral sleeve construct was revised.After exposing the knee, it was noted that the femoral component felt loose.When removed, the locking bolt was found loosened in the junction box.The sleeve and stem were well-fixed.

Manufacturer Narrative

The following information is not available due to the device was not returned, and the original surgery cannot be identified: lot, implant date, and device manufacture date.

Event Description

On (b)(6) 2021, a femoral sleeve construct was revised.After exposing the knee, it was noted that the femoral component felt loose.When removed, the locking bolt was found loosened in the junction box.The sleeve and stem were well-fixed.

Manufacturer Narrative

There was insufficient information provided to perform a definitive evaluation of this report.For example, the original surgery date was not provided or could not be determined, the parts were not returned, no lot numbers were provided, etc.Failure is likely due to the method of assembling the junction box locking bolt or loosening of the bolt in-vivo but cannot be determined with any certainty.

• Brand Name: BALANCED KNEE SYSTEM REVISION
• Type of Device: TOTAL KNEE PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer (Section G): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer Contact: drew weaver ; 12187 s. business park drive; draper, UT 84020 ; 8015539991
• MDR Report Key: 13120112
• MDR Text Key: 285678886
• Report Number: 1722511-2021-00017
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 561-0010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female