MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HIGH FLEXION INSERT SZ 7-8 9MM; PROSTHSISKNEPATLLOFMOROTIBIALSMICONSTRAINDUNCMNTDPOROUSCOATDPOLYMRMTALPOLYMR

Model Number	71421522
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a post broke on insert when patient was kneeling in the garden and then stood up.

• Brand Name: GII PS HIGH FLEXION INSERT SZ 7-8 9MM
• Common Device Name: PROSTHSISKNEPATLLOFMOROTIBIALSMICONSTRAINDUNCMNTDPOROUSCOATDPOLYMRMTALPOLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9631681
• Report Number: 1020279-2020-00382
• Device Sequence Number: 14142452
• Product Code: MBH
• UDI-Device Identifier: 03596010492975
• UDI-Public: 03596010492975
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 71421522
• Device Catalogue Number: 71421522
• Device Lot Number: 06FT98840
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 01/04/2021
• Patient Sequence Number: 1