MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII P/S CONS HOUSING REAM DOME; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71440145

Device Problem Dull, Blunt (2407)

Patient Problem No Patient Involvement (2645)

Event Date 06/15/2020

Event Type  malfunction  

Event Description

It was reported that the reamer has become dull due to wear and tear of use.No case involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The information received by the manufacturer has been re-evaluated for mdr reporting.The information states that event did not caused an injury and was not malfunction, 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 P/S CONS HOUSING REAM DOME
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10254708
• MDR Text Key: 198287385
• Report Number: 1020279-2020-03026
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010471338
• UDI-Public: 03596010471338
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71440145
• Device Catalogue Number: 71440145
• Device Lot Number: NOT READABLE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1