MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OVAL RESURFACING PAT 35MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71421035
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the clinical subject suffered from left knee arthrofibrosis following a surgery.The event was resolved via manipulation under anesthesia.

• Brand Name: GII OVAL RESURFACING PAT 35MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9911102
• Report Number: 1020279-2020-01111
• Device Sequence Number: 16983020
• Product Code: JWH
• UDI-Device Identifier: 03596010485076
• UDI-Public: 03596010485076
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2020

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: 71421035
• Device Catalogue Number: 71421035
• Device Lot Number: 17KM06060
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 12/10/2020
• 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