MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CON INS SZ7-8 30MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420564
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	07/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to subluxation.
Additional Manufacturer Narrative
The associated genesis ii constrained articular insert was returned and evaluated.A lab analysis conducted during this investigation indicated material deformation was observed around the anterior and posterior face of the as-received insert.Scratches and wear were visible on medial and lateral sides of the insert post indicating this constrained insert may have interacted with the femoral component during use.There was also wear observed on the articulating surface of the insert.Burnishing and wear was observed on the inferior surface with damage around the locking mechanism.No manufacturing deviations were noted during this investigation.Based on the investigation conducted, the exact cause of the reported subluxation was not able to be determined.Our investigation including a review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.The batch number was provided for the device.Thus, a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.There is no information that would suggest the implanted device failed to meet specifications.Our clinical evaluation noted the images provided were post left tka which show the insert anteriorly dislocated but a root cause is not known.The patient impact was the reported revision and an expected brief post-operative rehabilitative phase.No further medical assessment can be rendered at this time.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.

• Brand Name: GNS II CON INS SZ7-8 30MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8025321
• Report Number: 1020279-2018-02291
• Device Sequence Number: 11107750
• Product Code: JWH
• UDI-Device Identifier: 03596010208248
• UDI-Public: 03596010208248
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2019

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: 71420564
• Device Lot Number: D1605166
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 04/01/2019
• 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
• Patient Age: 25 YR