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
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2019
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: PROSTSIS KNE PATLOFMOROTIBIAL SMICONSTRIND CMNTD POLYMR ADTIVMTALPOLYMR ADTIV
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9029461
• Report Number: 1020279-2019-03347
• Device Sequence Number: 2219125
• Product Code: OIY
• UDI-Device Identifier: 00885556620939
• UDI-Public: 00885556620939
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K122529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1