MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PRO NON-POR TIB BASE L S4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71524240
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); No Information (3190)
Date of Event	04/24/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery for the profix knee was performed due to unspecified reasons.
Additional Manufacturer Narrative
Customer indicated that there is no product/device to be returned for investigation analysis.
Event or Problem Description
It was reported a revision surgery was performed due to anterior knee pain after a fall.Surgeon resurfaced the patella only.No items were explanted.

• Brand Name: PRO NON-POR TIB BASE L S4
• 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: 6501027
• Report Number: 1020279-2017-00277
• Device Sequence Number: 614501
• Product Code: JWH
• UDI-Device Identifier: 03596010228949
• UDI-Public: 03596010228949
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K933958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2017

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: 71524240
• Device Lot Number: 07AM16330
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: Not provided; 03/29/2017
• Initial Report FDA Received Date: 04/18/2017
• Supplement Report FDA Received Date: 04/25/2017; 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART#71507243 LOT#02JM11403, PRO CONF TB INSERT; PART#71522250 LOT#71522250, PROFIX NON-POR FEM LT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR