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

Catalog Number 71440145

Device Problem Product Quality Problem (1506)

Patient Problem No Patient Involvement (2645)

Event Date 05/14/2020

Event Type  malfunction  

Event Description

It was reported that during inspection was found that the gii p/s cons housing ream dome is dull.There was no case involved.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.A visual inspection was conducted and confirmed the housing reamer dome is dull.The lot number can¿t be read on the device.This device shows signs of extreme wear/usage.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.This device is reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII P/S CONS HOUSING REAM DOME
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10138753
• MDR Text Key: 194659433
• Report Number: 1020279-2020-02299
• Device Sequence Number: 1
• Product Code: MBH
• 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
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71440145
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1