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

Model Number 561-0510

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

Patient Problem Arthralgia (2355)

Event Type  Injury  

Event Description

In 2018 (exact date not provided), a patient received a total knee prosthesis in a previously infected knee.In 2019 (exact date not provided), a fungal infection developed and was treated with a spacer.In (b)(6) 2019 (exact day not provided), the patient was implanted with a sleeve and with continued anti fungals for suppression.After 7 months, the patient presented with increased pain.The knee was aspirated and appeared to have metal wear and x-rays showed an anterior femur fracture while the femoral component had translated anterior.In (b)(6), 2022 (exact day not provided), the femoral component was explanted and observed to be loose at the junction box rails.An above knee amputation was ultimately performed.

Manufacturer Narrative

Date of event - exact dates not provided for events.The field will not accept only month and year without a day.Implant date - exact day not provided.The field will not accept only month and year without a day.Explant date - exact day not provided.The field will not accept only month and year without a day.

• Brand Name: BALANCED KNEE REVISION SYSTEM
• 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: 16628272
• MDR Text Key: 312170813
• Report Number: 1722511-2023-00007
• Device Sequence Number: 1
• Product Code: MBH
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 561-0510
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2023
• 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 Age: 65 YR
• Patient Sex: Female