MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHEM PS HI-FLEX INSERT SIZE 1-2 11MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR

Catalog Number	71422662
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tibial component was disassociated from the insert.Re-surgery was performed.
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A clinical analysis indicated that several attempts have been made to obtain clinical/medical information to no avail.No supporting clinical/medical documents have been provided.Therefore a thorough investigation cannot be performed.A review of complaint history did not reveal additional complaints for the listed part.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: ANTHEM PS HI-FLEX INSERT SIZE 1-2 11MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7450756
• Report Number: 1020279-2018-00794
• Device Sequence Number: 1446057
• Product Code: JWH
• UDI-Device Identifier: 00885556583982
• UDI-Public: 00885556583982
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71422662
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention