MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II BICONVEX PAT 26MM; PROSTHESIS KNE PATELLOFEMOROTIBIAL SMI-CONSTRAINED CMNTED POLYMER/MTAL/POLYMER

Catalog Number	71420568
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/22/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to the discovery of a cyst behind the original poly patella.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A review of the photos does show the presence of a cyst.A clinical evaluation was conducted and without the requested clinical information, operative reports, or the explant, the root cause of the cyst formation cannot be determined.The future impact to the patient beyond the revision cannot be determined.No further clinical/medical assessment is warranted at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: GNS II BICONVEX PAT 26MM
• Common Device Name: PROSTHESIS KNE PATELLOFEMOROTIBIAL SMI-CONSTRAINED CMNTED POLYMER/MTAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8172426
• Report Number: 1020279-2018-02817
• Device Sequence Number: 1406356
• 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 Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019

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: 11/25/2021
• Device Catalogue Number: 71420568
• Device Lot Number: 11LM13871
• Initial Date Received by Manufacturer: 11/22/2018
• Supplement Date Received by Manufacturer: 11/22/2018
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 03/21/2019
• 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