MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CON INS SZ3-4 13MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420526
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery had to be performed on the patient to exchange liner's size.No delay specified.No injury reported.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that no revision surgery was performed and there was no serious injury to the patient, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: GNS II CON INS SZ3-4 13MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8702651
• Report Number: 1020279-2019-02281
• Device Sequence Number: 2211453
• Product Code: JWH
• UDI-Device Identifier: 03596010208057
• UDI-Public: 03596010208057
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2019

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: 71420526
• Device Lot Number: 15EM11398
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 06/16/2019
• Supplement Report FDA Received Date: 09/17/2019
• 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