MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GENESIS II C/R ARTICULAR INSERT SZ 3-4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	71420490
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/11/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a surgery was delayed by more than 30 minutes due to an insert that would not lock into the tibial baseplate.Another insert was used to complete the surgery.
Additional Manufacturer Narrative
Further information was received that indicated the delay in surgery was not greater than 30 minutes.Therefore, this report was submitted in error.No further actions are required.Please disregard this mdr.

• Brand Name: GENESIS II C/R ARTICULAR INSERT SZ 3-4 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6553909
• Report Number: 1020279-2017-00327
• Device Sequence Number: 11015518
• Product Code: JWH
• UDI-Device Identifier: 03596010207890
• UDI-Public: 03596010207890
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2017

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: 10/01/2026
• Device Catalogue Number: 71420490
• Device Lot Number: 16KM01040
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2017
• Supplement Report FDA Received Date: 05/23/2017
• 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