MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OVAL RESURFACING PAT 32MM; PROSTHSISKNEEPATELOFEMOROTIBIALSMICONSTRAINDCMNTDPOLYMRMTALPOLYMER

Model Number	71421032
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient presented stiffness of left knee.Event was treated with manipulation under anesthesia.

• Brand Name: GII OVAL RESURFACING PAT 32MM
• Common Device Name: PROSTHSISKNEEPATELOFEMOROTIBIALSMICONSTRAINDCMNTDPOLYMRMTALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9951760
• Report Number: 1020279-2020-01267
• Device Sequence Number: 3272598
• Product Code: JWH
• UDI-Device Identifier: 03596010485069
• UDI-Public: 03596010485069
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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: 71421032
• Device Catalogue Number: 71421032
• Device Lot Number: 17EM04755
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 04/11/2020
• Supplement Report FDA Received Date: 12/05/2020
• 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