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

Model Number	71421035
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/11/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the clinical subject had been experiencing problems associated with stiffness on his surgery knee.The subject attempted physical therapy but ended up developing arthrofibrosis.The event was treated via manipulation under anesthesia and its outcome is considered unknown.

• Brand Name: GII OVAL RESURFACING PAT 35MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,PLYMR/METAL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9983916
• Report Number: 1020279-2020-01338
• Device Sequence Number: 4482936
• Product Code: JWH
• UDI-Device Identifier: 03596010485076
• UDI-Public: 03596010485076
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 08/16/2021

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: 08/17/2026
• Device Model Number: 71421035
• Device Catalogue Number: 71421035
• Device Lot Number: 16HM13666
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 08/16/2021
• 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