MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II BICONVEX PAT 26MM; PROST, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLY/MET/POLY

Model Number	71420568
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to a patella that was "floating" inside the knee (confirmed by a pre-op x-ray).It was replaced with a 29mm resurfacing patella.(the first patella device was implanted about 10 years ago (unknown date)).No operative reports are available.
Additional Manufacturer Narrative
It was reported that revision surgery was performed due to a patella that was "floating" inside the knee.The patella device was implanted about 10 years ago with an unknown date.The affected genesis ii biconvex patellar component, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Possible causes could include but not limited to traumatic injury, abnormal motion over time or size of device.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: GNS II BICONVEX PAT 26MM
• Common Device Name: PROST, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLY/MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9533512
• Report Number: 1020279-2019-04703
• Device Sequence Number: 14113795
• Product Code: JWH
• UDI-Device Identifier: 03596010208262
• UDI-Public: 03596010208262
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2020

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: 71420568
• Device Catalogue Number: 71420568
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 05/14/2020
• 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