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

Model Number	71420568
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	01/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery took place due to the release of the biconvex patella button.The patient suffered pain and limited function. broken post behind the patella button was found with visual inspection.Primary surgery was performed 2.5 years ago.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The post is fractured off the device and it shows signs of extensive wear.The mating surface also has cement adhered to the surface.The clinical medical evaluation concluded that this case reports a revision was performed due to the release of the biconvex patella button, which was found intraoperatively to have a broken post.Per email correspondence, the requested surgical reports and x-rays are not available due to privacy regulations.Therefore, the clinical root cause of the event and the patient impact beyond the revision cannot be determined.Due to the limited information provided, a thorough assessment cannot be rendered.Should additional clinically relevant documentation become available, the clinical/medical task may be re-evaluated.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 do not have 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 that this failure mode and associated harm has been previously identified.Some potential probable causes of this event could include a procedural error, improper size of device used or a traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GNS II BICONVEX PAT 26MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11321695
• Report Number: 1020279-2021-01177
• Device Sequence Number: 4125474
• Product Code: JWH
• UDI-Device Identifier: 03596010208262
• UDI-Public: 03596010208262
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

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
• Device Lot Number: 710JM09820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 06/17/2021
• 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; Other; Required Intervention