MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII FEMORAL IMPACTOR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 71440190

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2018

Event Type  malfunction  

Event Description

Block cracked during final impaction.All pieces retrieved no debris left case not affected.No delay.Backup available.

Manufacturer Narrative

The associated complaint device was returned and evaluated.A visual inspection was conducted and confirmed the impactor shows damage at the acetal center alignment nodule that comes into contact with the femoral component.This damage appears to have been caused by an impact overload mechanism.The damage of the impactor was likely due to the impact forces applied to the instrument during seating of the femoral component.No destructive analysis was performed.It is unknown if the damage initiated in a previous surgery.The visual also revealed the bumper is loose and faded.The device was manufactured in 2007.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.If new information is received in the future, this complaint can be re-opened.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

Event Description

It was reported that one of the pegs broke off during final impaction.All pieces retrieved no debris left case not affected.No delay.Backup available.

Event Description

Block cracked during final impaction.All pieces retrieved no debris left case not affected.No delay.Backup available.

• Brand Name: GII FEMORAL IMPACTOR
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8201029
• MDR Text Key: 131586589
• Report Number: 1020279-2018-02928
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010214379
• UDI-Public: 03596010214379
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71440190
• Device Lot Number: 70903273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Date Manufacturer Received: 06/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1