MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NY BCS II FEMORAL OXIN RT SZ 8; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Catalog Number	74022118
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Death (1802)
Date of Event	09/03/2018
Type of Reportable Event	Death
Event or Problem Description
A patient's decease was reported 3 months after right total knee replacement.
Additional Manufacturer Narrative
The event was reported from a retrospective post market clinical study.Further follow up was performed with the clinical site and our internal adverse event monitoring board and it was determined that this event should be classified as not device related.
Event or Problem Description
The event was reported from a retrospective post market clinical study.Further follow up was performed with the clinical site and our internal adverse event monitoring board and it was determined that this event should be classified as not device related.

• Brand Name: NY BCS II FEMORAL OXIN RT SZ 8
• Common Device Name: PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7911108
• Report Number: 1020279-2018-01928
• Device Sequence Number: 1797829
• Product Code: JWH
• UDI-Device Identifier: 00885556170069
• UDI-Public: 00885556170069
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2018

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: 74022118
• Device Lot Number: 18BM10837
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 10/19/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 75 YR