MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII NONPOROUS PS FEM SZ 5 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIND, CEMENTD, POLY/MET/POLY

Model Number	71420104
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a infection.No more information available.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to an infection approximately 3 years post implantation.No more information was available.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device details were not made available, device history record and sterilization documentation review cannot be completed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.The lot is unknown for this part.No medical documents were received for investigation, therefore, the source of the unspecified infection could not be fully assessed.The provided photo of explanted components did not provide insight into the root cause of the reported infection.Some potential causes of the reported event could include but are not limited to patient medical history or patient reaction.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical records available, 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.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GII NONPOROUS PS FEM SZ 5 LT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIND, CEMENTD, POLY/MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10668132
• Report Number: 1020279-2020-05357
• Device Sequence Number: 2727401
• Product Code: JWH
• UDI-Device Identifier: 03596010205964
• UDI-Public: 03596010205964
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

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: 71420104
• Device Catalogue Number: 71420104
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 02/04/2021
• 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