MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VIVACIT-E ART SURF SZ 3 8MM; PROSTSIS KNE PATLOFMOROTIBIAL SMICONSTRIND CMNTD POLYMR ADTIVMTALPOLYMR ADTIV

Catalog Number 00584209308

Device Problem Incomplete or Inadequate Connection (4037)

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

Event Date 08/15/2019

Event Type  malfunction  

Event Description

It was reported that during surgery, the poly would not stay locked in the tibial base.Delay of less than 30 minutes, no injury reported.No backup device available, procedure was concluded with a poly one bigger size.

Manufacturer Narrative

The associated complaint packaging boxes were returned and evaluated.A visual inspection of the returned opened outer box showed no obvious signs of damage.The two inserts appeared discolored and damaged.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A dimensional inspection was attempted; the damage/deformation at several features of the device would not allow for accurate measurement.The features that could be measured were within specification.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.If the devices are received in the future, this complaint can be re-opened.

• Brand Name: VIVACIT-E ART SURF SZ 3 8MM
• Type of Device: PROSTSIS KNE PATLOFMOROTIBIAL SMICONSTRIND CMNTD POLYMR ADTIVMTALPOLYMR ADTIV
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9029461
• MDR Text Key: 158171240
• Report Number: 1020279-2019-03347
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00885556620939
• UDI-Public: 00885556620939
• Combination Product (y/n): N
• PMA/PMN Number: K122529
• 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: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 00584209308
• Device Lot Number: 64045826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Date Manufacturer Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1