MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES, INC. STRIDE UNICONDYLAR KNEE SYSTEM; UNICONDYLAR KNEE IMPLANT

Model Number 110039

Device Problems Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Arthralgia (2355)

Event Date 10/12/2015

Event Type  Injury  

Manufacturer Narrative

When it was explanted, we found the loosening of the component was due to excessive cement on the posterior aspect of the prosthesis.The abundant amount of cement created lift in the posterior aspect and loosened the anterior portion.The poly did not have any cracks, but had some slight indentation.After taking the implant out, the physician resized the tibia and found he wanted to move from the original tibia size of a 9 (pfsi-00018) to an 8 (pfsi-00016).The poly size e, 8mm (pfsi-00045) was replaced with a size d, 8mm (pfsi-00039) the same.He re-drilled for the tibial pegs and before cementing the new implant physician took the smallest drill point available and made additional holes.He did this, as he explained, to better hold the component.

Event Description

Physician conducted a revision of a patient that received a stride implant in late may.The patient came to physician complaining of tibial pain.An x-ray was done on the patient and the physician came to the conclusion that revision needed to be done because of loosening of the tibial component.

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 tibial component and it was found that the loosening of the component was due to excessive cement on the posterior aspect of the prosthesis: the abundant amount of cement created lift in the posterior aspect and loosened the anterior portion.After taking the implant out, the tibia was resized from a 9 to an 8.The physician re-drilled for the tibial pegs and, before cementing the new implant, the smallest drill point available was taken to make additional holes to better hold the component.The patient outcome is unknown.

Manufacturer Narrative

H10: g4, h2, h3, h6: updated information.H11: a1, b1, b5: corrected information.

• Brand Name: STRIDE UNICONDYLAR KNEE SYSTEM
• Type of Device: UNICONDYLAR KNEE IMPLANT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES, INC.; 2905 northwest blvd.; suite 40; plymouth MN 55441
• MDR Report Key: 5217750
• MDR Text Key: 30968705
• Report Number: 3010266064-2015-00004
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00841153100168
• UDI-Public: 00841153100168
• 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: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2015
• Device Model Number: 110039
• Device Catalogue Number: PFSI-00018
• Device Lot Number: C7449321
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2020
• 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