MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PATELLAR DEPTH STOP; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Catalog Number	71440326
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery inlay patella reaming and the depth stop slipped, resulting in over reaming of the patella.Surgeon was able to bone graft the defect and then cement the implant.Delay of 20 minutes reported.Surgeon states he needs to wait to see if any issue occurred as the patient recuperates.
Additional Manufacturer Narrative
The new information states that this event has already been reported under reference number 1020279-2019-01333, therefore, it was determined that this case does not meet the threshold for reporting and is duplicate event.If further details are provided, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.No further investigation warranted for this complaint.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that this event has already been reported under reference number 1020279-2019-01333, therefore, 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 PATELLAR DEPTH STOP
• Common Device Name: PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8489940
• Report Number: 1020279-2019-01407
• Device Sequence Number: 1633628
• Product Code: MBH
• UDI-Device Identifier: 03596010215000
• UDI-Public: 03596010215000
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2019

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: 71440326
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 03/13/2019; 03/13/2019
• Initial Report FDA Received Date: 04/07/2019
• Supplement Report FDA Received Date: 04/30/2019; 05/21/2019
• 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