MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 5-6 18; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71421519
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Dr did a poly exchange, due to a suspected infection.
Additional Manufacturer Narrative
The associated genesis ii ps high flexion insert was not returned for evaluation.The device was manufactured in 2012.Our investigation including a review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.Product was sterilized according to sterilization release documentation from quality control.A clinical evaluation indicated that no relevant information has been provided to conduct a thorough medical investigation.Therefore, no further clinical/medical assessment is warranted at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: GII PS HI FLEX ISRT SZ 5-6 18
• 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: 7716755
• Report Number: 1020279-2018-01391
• Device Sequence Number: 16424172
• Product Code: JWH
• UDI-Device Identifier: 03596010493835
• UDI-Public: 03596010493835
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2018

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: Lay User/Patient
• Device Catalogue Number: 71421519
• Device Lot Number: 12KT24294
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2018
• Supplement Date Received by Manufacturer: 07/08/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 11/20/2018
• 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