MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 7-8 RT 9; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74023271
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed for a poly swap on patient of a journey 1 implant.Customer asked for revision due to genuflecting knee.Surgeon decided to make an ex - change of the implant, while doing it post broke off insert.No delay.Back up device of s&n used.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.The lab analysis concluded, this examination showed a fracture of the tibial post and features of deformation, wear, and surface damage on the insert.The indentions that were shown on the insert may have been from seating the insert as well as removal of the insert.The delamination could have been caused by attempting to remove the insert as well.The cause of the post fracture upon removal could not be determined from the investigation of the device.No evidence of material or manufacturing deviations were observed in this investigation.The clinical/medical team concluded, no relevant clinical medical information was provided to conduct a thorough medical assessment.The product evaluation revealed no evidence of material or manufacturing deviations during the investigation.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.If new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: JOURN ART INS BCS STD 7-8 RT 9
• 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: 8297027
• Report Number: 1020279-2019-00369
• Device Sequence Number: 2141793
• Product Code: JWH
• UDI-Device Identifier: 03596010555274
• UDI-Public: 03596010555274
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019

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: 74023271
• Device Lot Number: 10AM03349
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 02/01/2019
• Supplement Report FDA Received Date: 06/12/2019
• 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