MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II RESURF PAT 32MM; PRSTHSISKNEEPTLLOFMRTIBLSMI-CNSTRINDCMNTDPLYMRMTALPLYMR

Model Number	71420576
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patella component was disassociated.An open reduction was performed to correct the issue.No components explanted.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that it was reported that the patella component was disassociated and a revision surgery will be performed on an unknown date.The patella component seemed to be disassociated and an open reduction was done on in which no components were explanted.It is also noted that the patient sustained a fall and the doctor does not consider as product failure.No surgical reports or medical imaging were provided.No further clinical assessment is warranted at this time.In the event additional medical/clinical records are received, the clinical task will be re-opened and a thorough assessment will be rendered at that time.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes of this event could include a sizing/ fit issue or traumatic injury.

• Brand Name: GNS II RESURF PAT 32MM
• Common Device Name: PRSTHSISKNEEPTLLOFMRTIBLSMI-CNSTRINDCMNTDPLYMRMTALPLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9516106
• Report Number: 1020279-2019-04575
• Device Sequence Number: 19366286
• Product Code: JWH
• UDI-Device Identifier: 03596010208309
• UDI-Public: 03596010208309
• Combination Product (Y/N): N
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2020

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: 71420576
• Device Catalogue Number: 71420576
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 12/24/2019
• Supplement Report FDA Received Date: 03/22/2020
• 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