MAUDE Adverse Event Report: VLP 2.7MM PERC CALC PLT LG LT 62MM STER; PLATE, FIXATION, BONE

Model Number 72821020S

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

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, 4 months after a procedure with vlp 2.7mm perc calc plt lg lt 62mm ster was conducted to treat a calcaneus fracture, the patient experienced a deep unspecified infection and extensive pain.The devices were explanted, but it is unknown if they were replaced with another prosthesis.3 months later, the fracture healed completely as shown by radiographic confirmation.This incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered; therefore, additional information is not known and it is not possible to collect it.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per the complaint, the information in this article was noticed during a retrospective post-market clinical follow up activity (pmcf).However, smith and nephew has not received the device/adequate clinical documentation to fully evaluate the complaint.Without the requested relevant patient-specific clinical information a thorough medical investigation cannot be rendered.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed device.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but are not limited to contamination, joint tightness, material in use, patient reaction, patient reaction, and post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.G2: report source update g4: add 510k code h6: update codes.

• Brand Name: VLP 2.7MM PERC CALC PLT LG LT 62MM STER
• Type of Device: PLATE, FIXATION, BONE
• MDR Report Key: 12512692
• MDR Text Key: 272689450
• Report Number: 1020279-2021-07063
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00885556186862
• UDI-Public: 00885556186862
• Combination Product (y/n): N
• PMA/PMN Number: K110670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72821020S
• Device Catalogue Number: 72821020S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other