MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II RESURF PAT 26MM; PROSTHSIS KNEEPATELLOFMOROTIBIL SEMCNSTRAIND CMNTEDMETALPOLYMER

Catalog Number	71420580
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patella became "loose" in patient.Dr (b)(6) revised the patients knee to correct it.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection of the returned patella indicated damage to the articulating surface/ profile.There was the presence of cement around the connection pegs.A lab analysis indicated that wear on the articular surface was likely due to normal articulation between the insert and femoral component.The insert disassociation likely occurred following the fracture of the posterior locking mechanism.The cause of the fracture could not be determined from the available data.Further damage to the inferior surface of the insert could have been caused by the insert riding on top of the baseplate following disassociation.No material or manufacturing deviations were observed during this investigation.A clinical analysis indicated that it was reported that the patella was revised due to loosening.There have been no supporting medical records provided for review.There is no report of the patient's current condition or ho the procedure was tolerated.No further clinical assessment is warranted.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.Should additional information be received, the complaint will be reopened.

• Brand Name: GNS II RESURF PAT 26MM
• Common Device Name: PROSTHSIS KNEEPATELLOFMOROTIBIL SEMCNSTRAIND CMNTEDMETALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7081479
• Report Number: 1020279-2017-01185
• Device Sequence Number: 16395002
• Product Code: JWH
• UDI-Device Identifier: 03596010208323
• UDI-Public: 03596010208323
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2018

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: Lay User/Patient
• Device Catalogue Number: 71420580
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 12/04/2017
• Supplement Report FDA Received Date: 04/03/2018
• 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: 70 YR