MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STEM INSERTER FRAME; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71364008

Device Problem Unstable (1667)

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

Event Date 05/15/2021

Event Type  malfunction  

Event Description

It was reported that, during thr surgery, a stem impactor rod (case-(b)(4)) and a stem inserter frame (case-(b)(4) were noticed to be loose upon impaction, and could not be tightened enough to get firm fixation between them.There was a surgical delay less than 30 minutes reported due to this event, and the procedure was concluded using smith and nephew backup devices.Neither patient injury nor other complications were reported.

Manufacturer Narrative

H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned stem inserter frame confirmed the device is bent at the tip rendering the device inoperable.The device shows signs of extensive use.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.

• Brand Name: STEM INSERTER FRAME
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11914395
• MDR Text Key: 253558797
• Report Number: 1020279-2021-04889
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010199249
• UDI-Public: 03596010199249
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

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 Expiration Date: 05/20/2008
• Device Model Number: 71364008
• Device Catalogue Number: 71364008
• Device Lot Number: 80305084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Manufacturer Received: 05/15/2021
• Initial Date FDA Received: 06/01/2021
• Supplement Dates Manufacturer Received: 08/02/2021
• Supplement Dates FDA Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1