MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES STRIDE; UNICONDYLAR KNEE IMPLANT

Catalog Number PFSI-00027

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Arthralgia (2355)

Event Date 08/19/2015

Event Type  Injury  

Manufacturer Narrative

A poly exchange was performed due to infection in the patients right knee.The exchange and wash was done by dr.(b)(6) of the (b)(6).Note: the explanted implant was a stride b8 poly or (b)(4).Dr.(b)(6) said she didn't know the cause.She said the patient started having pain and fevers about a month ago.Device not received from hospital.

Event Description

A stride unicondylar knee implant tibial poly exchange was performed due to infection and pain in the patients right knee.

Event Description

It was reported that, after an ukr surgery in which a stride system had been implanted, the patient started experiencing pain and fever as consequence of an infection.A revision surgery was performed to exchange the size b 8 mm insert and to wash the affected area.The patient outcome is unknown.

Manufacturer Narrative

H10: b5, g4, h2, h3, h6: updated information.

Manufacturer Narrative

H10: the device, used in treatment, was not made available to the designated complaint unit for investigation.Thus, visual and functional inspection could not be performed.Dhr review found that no conditions which could contribute to the reported event were identified.This information is reasonably suggesting that the device met the specifications at the date when it was released to the distribution.A complaint history review did not find similar reports.This failure mode is identified within the risk assessment.The stride unicondylar knee system surgical technique, manual instrumentation, and product specifications provides instruction for femoral sizing, tibial sizing, and explantation.A relationship between the device and the reported event could not be established.The surgeon performed a procedure to cleanse the infected area and the precautionary poly exchange to correct pain due to infection and the root cause could not be determined.Per complaint details, the revision was performed due to pain and fevers secondary to a r knee infection; although the root cause of the infection remains unknown.Based on the information provided, a device failure was not supported and the patient impact beyond the reported events could not be determined; however, no patient injury was reported.No further medical assessment could be rendered at this time.

• Brand Name: STRIDE
• Type of Device: UNICONDYLAR KNEE IMPLANT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd.; suite 40; plymouth MN 55441
• MDR Report Key: 5082089
• MDR Text Key: 25991220
• Report Number: 3010266064-2015-00002
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K123380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Followup,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2016
• Device Catalogue Number: PFSI-00027
• Device Lot Number: C824971
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 68