MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II BICONVEX PAT 32MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Catalog Number	71420572
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a second stage revision was performed due to infection and loosening.
Additional Manufacturer Narrative
It was reported that a second stage revision was performed due to infection and loosening.The associated legion oxinium constrained femoral component, legion revision tibial baseplate, genesis ii biconvex patellar component, legion pos femoral wedge, and legion pressfit stem were not returned for evaluation.Thus a product evaluation could not be performed.However, device details were provided.Thus, the review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Based on the limited information provided, the clinical analysis noted the second revision was most likely due to a latent infection/recurrence.The patient impact beyond the revision procedure and expected medical interventions for infection cannot be determined.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.We consider this investigation closed.

• Brand Name: GNS II BICONVEX PAT 32MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8813871
• Report Number: 1020279-2019-02706
• Device Sequence Number: 3147231
• Product Code: JWH
• UDI-Device Identifier: 03596010208286
• UDI-Public: 03596010208286
• Combination Product (Y/N): N
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2019

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: 08/18/2023
• Device Catalogue Number: 71420572
• Device Lot Number: 13HM14319
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 11/25/2019
• 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: Required Intervention