MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HIGH FLEXION INSERT SZ 1-2 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71421501
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during a literature review, after first revision surgery from complaint (b)(4) , one month following the revision the patient developed a postoperative infection secondary to a (b)(4), which ultimately required a two-stage revision surgery.
Additional Manufacturer Narrative
The associated genesis ps high flexion insert was not returned for evaluation.This event was reported from a literature review.After repeated requests, smith and nephew has been unable to obtain device details.Smith and nephew has an outstanding request with the reporter for information.As device details were not made available, device history record review cannot be completed.Also, a complaint history review and sterilization documentation review could not be performed due to lack of device information.Our clinical evaluation noted that based on the article, the first revision was precipitated by the dislocation of the insert secondary to a fall from a bus.The root cause of the methicillin-resistant staphylococcus aureus that resulted in the second revision cannot be concluded but is not due to a failure of the device or procedure.With no supporting clinical/medical documents a thorough investigation cannot be performed.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.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: GII PS HIGH FLEXION INSERT SZ 1-2 9MM
• 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: 7996288
• Report Number: 1020279-2018-02255
• Device Sequence Number: 13799559
• Product Code: JWH
• UDI-Device Identifier: 03596010492388
• UDI-Public: 03596010492388
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2019

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: 71421501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 04/12/2019
• 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: Other; Required Intervention
• Patient Age: 60 YR