MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII NONPOROUS PS FEM SZ 8 RT; PRSTHSSKNEEPTLLOFMROTBLSMICNSTRINDCMNTDPLYMRMTALPLYMR

Model Number	71420126
Medical Device Problem Code	Failure to Shut Off (2939)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a knee infection.
Additional Manufacturer Narrative
This event was already reported under mdr no.: 1020279-2019-04378, therefore, it was determined that this case does not meet the threshold for reporting and is a duplicate report.If further details are provided, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: GII NONPOROUS PS FEM SZ 8 RT
• Common Device Name: PRSTHSSKNEEPTLLOFMROTBLSMICNSTRINDCMNTDPLYMRMTALPLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9443819
• Report Number: 1020279-2019-04346
• Device Sequence Number: 3231700
• Product Code: JWH
• UDI-Device Identifier: 03596010206077
• UDI-Public: 03596010206077
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2020

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 Model Number: 71420126
• Device Catalogue Number: 71420126
• Device Lot Number: 16BM07664
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 05/12/2020
• 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