MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES INC STRIDE UNICONDYLAR KNEE

Catalog Number PFSI-00022

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348); Arthralgia (2355)

Event Date 06/03/2015

Event Type  Injury  

Event Description

Patient was experiencing knee instability and pain.Surgeon performed an exchange of poly inserts to tighten the knee instability and curb the pain.Surgeon also noted that a contributing factor in his decision to perform a revision was the painful subcutaneous sutures.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

The screen shots from the patient archive file show that the original implant placement plan allowed the knee to be a little loose in extension.From 0 to 30 degrees of flexion, the planned gap was between 2-3 mm.Recommended range in extension is 0-2 mm.The photos of the explanted poly insert show a wear pattern consistent with original testing of the poly inserts and visually appear to be normal.There was a gouge in the anterior portion of the poly inesert that does not seem to be consistent with normal wear but a healthy knee would not contact the insert in that area.The "gouge" was most likely caused during the explant.Again, this is not an area of the poly insert that is in contact with the femoral implant and is not believed to be the cause of any of the patient's symptoms.It is our conclusion, with the help of surgeon feedback, that the pain and instability shown in the patient was due to the hyperextension and acl deficiency, causing instability in the joint, and subcutaneous sutures resulting in pain, but neither the instability or pain were concluded to be a result of the implant itself.The reason for increasing the insert thickness during the explant and poly exchange was to stabilize the joint due to acl deficiency.

Manufacturer Narrative

H10: g4, h2, h3, h6: updated information.H11: b5, b6, b7: corrected information.

Event Description

It was reported that, after an ukr surgery in which a stride system had been implanted, the patient was experiencing knee instability and pain.A revision surgery was performed to remove the size a 9 mm insert.The physician noticed that some of the pain was due to subcutaneous sutures.The poly was removed by impacting a curved osteotome on the most anterior portion of the poly in order to undermine the snaplock and lever insert out.After removal, a strange wear pattern was observed near the anterior portion of the implant.During placement of the new component, it was noticed that the patient had hyperextension and acl deficiency, which could have led to the the loose joint and strange wear pattern in the insert.In order to fix this, the size a 9 mm insert was replaced with a size a 10 mm insert.The patient outcome is unknown.

Manufacturer Narrative

H10: the device, used in treatment, was not returned for a prior investigation but pictures were provided.The case screenshots and patient archive file were also returned.The initial visual investigation found that: the wear pattern on the insert was comparable to the standard wear pattern shown in testing.The pain and instability shown in the patient was due to the hyperextension (instability), subcutaneous sutures (pain) and acl deficiency (instability and pain), not the implant itself.No issues were found with the device.The stride unicondylar knee system surgical technique, manual instrumentation, and product specifications provides instruction for femoral sizing, tibial sizing, and explantation.Device history record 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.A relationship between the device and the reported event could not be established.Per complaint details, the revision was performed due to knee instability and pain.Per the field report, some pain was due to subcutaneous sutures.Also noted intraoperatively by the surgeon was hyperextension and acl deficiency "which could have led to the loose joint and strange wear pattern".Per the product evaluation, a device failure was not supported.Based on the information provided, 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 UNICONDYLAR KNEE
• Type of Device: STRIDE UNICONDYLAR KNEE
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES INC; plymouth MN
• MDR Report Key: 4892425
• MDR Text Key: 6537811
• Report Number: 3010266064-2015-00001
• 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,company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2015
• Device Catalogue Number: PFSI-00022
• Device Lot Number: 6672221
• Other Device ID Number: (01)00541153100212
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/03/2015
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 68