MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II BICONVEX PAT 29MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLY/METAL/POLY

Catalog Number	71420570
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	07/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to increased pain.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.A review of the complaint history revealed no prior complaints for the listed lots.Our clinical/medical team concluded that based on the documentation provided, the patient¿s high-risk for infection/comorbidities cannot be ruled out as the major contributing factors to the reported early post-operative symptoms and does not suggest a mal-performance of the prosthetic components, rather, a post-op complication of the surgical procedure itself.The reported 2nd aspiration was performed after a traumatic fall and was deemed hemarthrosis, due to said injury and negative infection; however the patient continued on chronic prophylactic antibiotics.Although there was mention of a right tka revision in 2018, documentation regarding this event has not been provided for inclusion in the medical investigation.The patient impact was the reported post-operative complication of mrsa infection and resulting symptoms necessitating chronic prophylactic antibiotics, the 2 aspirations and the reported revision.Should additional documentation be provided, the medical investigation assessment may be re-evaluated.No further medical assessment can be rendered at this time.A definitive root cause cannot be determined with the information provided.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.

• Brand Name: GNS II BICONVEX PAT 29MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8146348
• Report Number: 1020279-2018-02727
• Device Sequence Number: 14019965
• Product Code: JWH
• UDI-Device Identifier: 03596010208279
• UDI-Public: 03596010208279
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• 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 Expiration Date: 10/17/2025
• Device Catalogue Number: 71420570
• Device Lot Number: 15KM13945
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 12/10/2018
• 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: Hospitalization; Other
• Patient Age: 69 YR