MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II RESURF PAT 29MM; PROSTHESIS, KNE, PATELOFEMOROTBIAL, SMI-CONSTRAINED, CEMNTD, POLYMR/METL/POLYMER

Catalog Number	71420574
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
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 perform due to a patella loosening.Patella and insert were replaced.
Additional Manufacturer Narrative
The affected genesis ii resurfacing patellar component was not returned for evaluation.Our investigation including a review of complaint history revealed no additional complaints for the listed batch with the same failure mode.The device was manufactured in 2014.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A clinical evaluation noted that no supporting clinical documentation and no report of the patient's current condition was provided.Therefore based on insufficient information, no further clinical assessment can be performed at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.Credit cannot be issued for this device.

• Brand Name: GNS II RESURF PAT 29MM
• Common Device Name: PROSTHESIS, KNE, PATELOFEMOROTBIAL, SMI-CONSTRAINED, CEMNTD, POLYMR/METL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8112826
• Report Number: 1020279-2018-02628
• Device Sequence Number: 1616554
• Product Code: JWH
• UDI-Device Identifier: 03596010208293
• UDI-Public: 03596010208293
• 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: 2017
• 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): 02/19/2019

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: 06/27/2024
• Device Catalogue Number: 71420574
• Device Lot Number: 14FM21062
• Initial Date Received by Manufacturer: 11/22/2018
• Supplement Date Received by Manufacturer: 11/22/2018
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART NUMBER 71453173/LOT 16KM10046; PART NUMBER 71453173/LOT 16KM10046
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention