MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Catalog Number	74022114
Medical Device Problem Code	Incorrect Device Or Component Shipped (2962)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a left side implant was in a package labeled as a right side implant.The incorrect implant was implanted but was noticed to be incorrect.The left component was removed and a back-up right component was implanted.The surgery was delayed by more than two hours.
Additional Manufacturer Narrative
The associated device was returned and evaluated.Our investigation confirmed that the device had been swapped/mis-packaged; a size 5 left femoral implant was placed in the size 4 right packaging.Limited information was given to contribute to a medical investigation.It was communicated that surgery was delayed for three hours, yet no patient injury has been reported subsequent to the reported event.No further clinically relevant documentation was provided for inclusion in a medical investigation.A quality hold has been placed in an attempt to quarantine and re-inspect additional devices from the listed batches.This event has been elevated to our risk assessment process to determine if/what additional actions are needed.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 4
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7260080
• Report Number: 1020279-2018-00139
• Device Sequence Number: 11009903
• Product Code: JWH
• UDI-Device Identifier: 00885556169865
• UDI-Public: 00885556169865
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 04/11/2018

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: 74022114
• Device Lot Number: 17KM22618
• Initial Date Received by Manufacturer: 02/09/2018
• Supplement Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 02/09/2018
• Supplement Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: QRB 2018-021/HHE 2018-22
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization