MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII INTRA TIB ALIGNMENT; PROSTHESIS,KNEE,FEMOROTIBIAL,SEMICONSTR,CEMENT,MET/POLY

Model Number	71440200
Medical Device Problem Codes	Connection Problem (2900); Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a genesis ii intra tib alignment was worn out and was not able to lock down, so the cutting block is not secure.No harm or injury reported on patient.Procedure was finished with a smith and nephew back up device.No delay reported.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: GII INTRA TIB ALIGNMENT
• Common Device Name: PROSTHESIS,KNEE,FEMOROTIBIAL,SEMICONSTR,CEMENT,MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10791319
• Report Number: 1020279-2020-06207
• Device Sequence Number: 3204422
• Product Code: HRY
• UDI-Device Identifier: 03596010214423
• UDI-Public: 03596010214423
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• 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): 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71440200
• Device Catalogue Number: 71440200
• Device Lot Number: 10HST005
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1