MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HIGH FLEXION INSERT SZ 7-8 9MM; PRSTHESIS,KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71421522
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to dislocated patella implant revised: swapped a genesis ii 7-8 9mm poly to a legion 7-8 9mm poly.Original poly exhibited no signs of wear or damage, and was swapped out just as an infection control precaution.
Additional Manufacturer Narrative
The associated genesis ii biconvex patellar component and genesis ii ps high flexion insert were not returned for evaluation.A clinical evaluation conducted during this investigation noted that an insufficient relevant information was provided, therefore, a through medical assessment cannot be performed at this time.However, it was reported that the revision was due to patellar instability, ¿not a product issue¿ and the poly was revised ¿due to infection risk¿.The patient impact beyond the reported patellar instability, subsequent revision procedure (mpfl reconstruction performed to relocate the patella, a lateral facetectomy through the edge of the patella implant) and poly exchange cannot be determined.No further medical assessment is warranted at this time.As batch numbers were not made available, a device history record review cannot be completed at this time.A complaint history review could not be performed with any accuracy due to lack of lot numbers.Without the return of the actual product involved and no batch information available, our investigation of this report is inconclusive.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: GII PS HIGH FLEXION INSERT SZ 7-8 9MM
• Common Device Name: PRSTHESIS,KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7921058
• Report Number: 1020279-2018-02002
• Device Sequence Number: 11131026
• Product Code: JWH
• UDI-Device Identifier: 03596010492975
• UDI-Public: 03596010492975
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2019

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: 71421522
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 09/29/2018
• Supplement Report FDA Received Date: 03/13/2019
• 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