MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PROFIX {} C/R HA POR FEM SZ 5 LT; PRSTHSS,KNEE,PATELLO/FMOROTBIAL,SMI-CNSTRND,UNCMNTD,POROUS,COTED,PLYMR/MTL/PLYMR

Model Number	71503250
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Pain (1994); Joint Disorder (2373)
Date of Event	03/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent revision total knee replacement surgery for an unstable knee and continuing increase of pain over a number of years.The original knee surgery was performed in (b)(6) 2005.It was reported that the femur had loosened and that the bone quality was quite poor.
Additional Manufacturer Narrative
It was reported that the patient underwent revision total knee replacement surgery for an unstable knee and continuing increase of pain over a number of years.The original knee surgery was performed in (b)(6) 2005.It was reported that the femur had loosened and that the bone quality was quite poor.The knee was assessed as stable at completion of revision operation.

• Brand Name: PROFIX {} C/R HA POR FEM SZ 5 LT
• Common Device Name: PRSTHSS,KNEE,PATELLO/FMOROTBIAL,SMI-CNSTRND,UNCMNTD,POROUS,COTED,PLYMR/MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9881262
• Report Number: 1020279-2020-01017
• Device Sequence Number: 3041077
• Product Code: MBH
• UDI-Device Identifier: 03596010484710
• UDI-Public: 03596010484710
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K030623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2020

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 Expiration Date: 09/07/2014
• Device Model Number: 71503250
• Device Catalogue Number: 71503250
• Device Lot Number: 04GM17371B
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 07/06/2020
• 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
• Patient Age: 72 YR