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 manufacturer has identified that this event should be re-evaluated for mdr reporting as it was determined that this case does not meet the threshold for reporting since the alleged malfunction has not caused or contributed to death or serious injury, and it is not likely that the recurrence of this alleged malfunction causes death or serious injury if it were to recur.Therefore, this event is a non-reportable event pursuant 21 c.F.R section 803.

• 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: 10248413
• MDR Text Key: 198075138
• Report Number: 1020279-2020-02997
• 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: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• 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: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1