MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES STRIDE POLY INSERT SIZE E 8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number PFSI00045

Device Problem Dent in Material (2526)

Patient Problem Arthralgia (2355)

Event Date 10/12/2015

Event Type  Injury  

Event Description

It was reported that, after an ukr surgery in which a stride system had been implanted, the patient complained of tibial pain.Diagnostic x-ray examination was performed and showed loosening of the tibial component.A revision surgery was performed to explant the 8 mm insert and it was found that it did not have any cracks, but had some slight indentation.The insert was substituted with another one of the same size.The patient outcome is unknown.

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.There was no serial number, lot number, or part number noted in the initial investigation documents so we are unable to conduct a device history record review as a part of the investigation.A complaint history review found similar report.This failure mode is identified within the risk assessment.The stride unicondylar knee system surgical technique, manual instrumentation, and product specifications provides instruction for implantation with cement.A relationship between the device and the reported event could not be established.Based on the information provided, the surgeon reported that the error was in the amount of cement and not an implant malfunction.The root cause could not be determined at this time.Per complaint details, the revision was performed due to pain secondary to loosening as a result of excessive cement on the posterior aspect of the prosthesis; therefore, it does not support a device failure.Based on the information provided, the patient impact beyond the reported pain, component loosening and subsequent revision could not be determined, as no patient injury was reported.No further medical assessment could be rendered at this time.

• Brand Name: STRIDE POLY INSERT SIZE E 8MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd; suite 40; plymouth, mn
• MDR Report Key: 9994338
• MDR Text Key: 188806970
• Report Number: 3010266064-2020-01163
• 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: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSI00045
• Device Lot Number: UNKNOWN
• 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: 54 YR
• Patient Weight: 68