MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HIGH FLEXION INSERT SZ 5-6 13MM; PROSTHESISKNEPATELOFMOROTIBIALSMICONSTRAINDUNCMNTDPOROUSCOATDPOLYMRMTALPOLYMR

Model Number	71421517
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due a unstable knee.Patient had a fall on his knee and it was discovered that the insert had broken off.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due an unstable knee.Patient had a fall on his knee and it was discovered that the insert had broken off.The affected genesis ii ps high flexion insert, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.A complaint history review found related failures; this failure mode will be trended by post market surveillance to assess for any necessary corrective actions.There is no information that would suggest the implanted device failed to meet specifications.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.The patient fall is likely probable cause of the reported event.Without the return of the actual product involved and no batch information provided, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: GII PS HIGH FLEXION INSERT SZ 5-6 13MM
• Common Device Name: PROSTHESISKNEPATELOFMOROTIBIALSMICONSTRAINDUNCMNTDPOROUSCOATDPOLYMRMTALPOLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9142249
• Report Number: 1020279-2019-03528
• Device Sequence Number: 14205200
• Product Code: MBH
• UDI-Device Identifier: 03596010492951
• UDI-Public: 03596010492951
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2020

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: 71421517
• Device Catalogue Number: 71421517
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 01/23/2020
• 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
• Patient Age: 56 YR