MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES STRIDE TIBIA BASEPLATE SIZE 2 LM/RL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number PFSI00004

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/09/2017

Event Type  Injury  

Event Description

It was reported that, during an ukr surgery, it was noticed that the stride tibia baseplate size 2 lm/rl was expired before the patient was taken to the or suite; nevertheless, the surgeon decided to proceed with the surgery as scheduled.The patient was not injured beyond the reported allegation.

Manufacturer Narrative

H10: the device, used in treatment, was not returned for investigation.Thus, visual inspection and functional evaluation could not be performed.It was reported that the surgeon knowingly implanted an expired tibial implant.The initial investigation found that: the device history record and inspection records revealed that the correct expiration date was 2017-04.Therefore, the implant was expired at the time of implant.Review of the dhr confirmed that there was a labeling issue with the lot of this implant, however the issue would not have contributed to the reported issue.A complaint history review did not identify similar reports.This failure is an identified failure mode within the risk file.A relationship between the device and the reported event could be established.Based upon the reported event description, this failure had been previously attributed to user error.Per complaint details, this represents a procedural variance which does not represent a device malfunction.Based on the information provided, the surgeon elected to use an implant that was approximately 9 days post expiration.S+n does not guarantee sterility post expiration as this could increase the patient's risk for infection; however, there was no patient injury/impact reported.Therefore, no further medical assessment is warranted at this time.

• Brand Name: STRIDE TIBIA BASEPLATE SIZE 2 LM/RL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9993716
• MDR Text Key: 188844059
• Report Number: 3010266064-2020-00484
• 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,health
• 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: 04/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PFSI00004
• 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): Other