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

Catalog Number	71420568
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to implant loosening.Revised to inlay resurfacing patella.
Additional Manufacturer Narrative
The associated genesis ii biconvex patellar component was returned and evaluated.Our investigation including the lab analysis indicated that minor scratches and burnishing that were observed on the articular surface of the patella implant could have been caused by third-body particulate (bone, bone cement, etc.), or during removal of the implant.Cement was observed to be still embedded in the cement surface implant and minor damage was observed on the fixation peg.On the basis of this investigation, the root cause of this failure mode could not be determined, and no material or manufacturing deviations were observed.In addition, a review of manufacturing records was conducted which did not reveal any deviation from the standard manufacturing processes.The review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.A clinical evaluation noted that no relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.There is no information that would suggest the implanted device failed to meet specifications.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• 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 road; memphis TN 38116
• MDR Report Key: 8610530
• Report Number: 1020279-2019-01943
• Device Sequence Number: 11201623
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2019

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 Catalogue Number: 71420568
• Device Lot Number: 16AM09002
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 08/19/2019
• 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