MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHEM PS HI-FLEX INSERT SIZE 3-4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71422667
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Poly removal.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, insufficient clinically relevant supporting documentation was provided to perform a thorough medical investigation.Therefore, no further medical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: ANTHEM PS HI-FLEX INSERT SIZE 3-4 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7368683
• Report Number: 1020279-2018-00480
• Device Sequence Number: 18880500
• Product Code: JWH
• UDI-Device Identifier: 00885556583944
• UDI-Public: 00885556583944
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 07/31/2018

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: Lay User/Patient
• Device Catalogue Number: 71422667
• Device Lot Number: 17HM16060
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2018
• Supplement Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 03/24/2018
• Supplement Report FDA Received Date: 07/31/2018
• 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