MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II RESURF PAT 32MM; PROST, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLY/MET/POLY

Model Number	71420576
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	02/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to pain and infection.The doctor said that the devices did not defect.He resolved patella loosening due to infection after tka surgery.
Additional Manufacturer Narrative
The devices, used in treatment, was not returned for evaluation and the reported event could not be confirmed.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents for this failure mode was conducted and concluded this failure mode has been identified.A sterilization review could not be performed without the batch numbers.Our clinical/medical team concluded: per subsequent email, the requested clinical information will not be provided for inclusion in this medical investigation.Therefore, a thorough medical investigation cannot be rendered.Should any additional medical information be provided this complaint will be re-assessed.No root cause could be determined with the information provided.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GNS II RESURF PAT 32MM
• Common Device Name: PROST, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLY/MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9729919
• Report Number: 1020279-2020-00645
• Device Sequence Number: 19378033
• Product Code: JWH
• UDI-Device Identifier: 03596010208309
• UDI-Public: 03596010208309
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 10/30/2020

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: 71420576
• Device Catalogue Number: 71420576
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 10/30/2020
• 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