MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II 7.5MM RESUR PAT 29MM; PROST, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLY/MET/POLY

Model Number 71932635

Device Problem Material Separation (1562)

Patient Problem Injury (2348)

Event Date 01/15/2020

Event Type  Injury  

Event Description

It was reported that patella fracture, loosening of patella component, and dislocation were diagnosed.On (b)(6) 2019, the initial surgery was performed.On an unknown date, the patella was fractured.And the patella component was loose and disassociated.Revision surgery was performed on (b)(6) 2020, where the patella and insert were revised.

• Brand Name: GEN II 7.5MM RESUR PAT 29MM
• Type of Device: PROST, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLY/MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9676189
• MDR Text Key: 177957278
• Report Number: 1020279-2020-00466
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556056516
• UDI-Public: 00885556056516
• Combination Product (y/n): N
• PMA/PMN Number: K951987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71932635
• Device Catalogue Number: 71932636
• Device Lot Number: 18GM14136
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74027232,18HM08520,JRNYIIBCSARTISRTSZ3-4-RT10MM; 74027232,18HM08520,JRNYIIBCSARTISRTSZ3-4-RT10MM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR