MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII POST REF FEM ALIGN GDE; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71440850

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2020

Event Type  malfunction  

Event Description

It was reported that the bolt/screw is missing from the gii post ref fem align gde.This could happened during sterilization process.Malfunction was found during set up/inspection in tka procedure.There was no delay.A s&n back up device was available to complete the procedure.No injuries reported at this time.

Manufacturer Narrative

Component code, guide.

Manufacturer Narrative

H3, h6: the associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device could confirm the stated failure mode.The screw on the device is missing, rendering the device inoperable.The device shows signs of extensive use.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII POST REF FEM ALIGN GDE
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10979958
• MDR Text Key: 220632668
• Report Number: 1020279-2020-07311
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010390394
• UDI-Public: 03596010390394
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71440850
• Device Catalogue Number: 71440850
• Device Lot Number: 15LCT0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 06/04/2021; 06/16/2021
• Supplement Dates FDA Received: 06/07/2021; 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1