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

Model Number 71440005

Device Problems Fracture (1260); Connection Problem (2900)

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

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

The sample is under evaluation by manufacturing site.

Event Description

It was reported that, during set up, it was noticed that a femoral implant impactor does not grab anymore.The procedure was finished without delay using a smith and nephew back up device.Patient was not harmed as consequence of this problem.On investigation results it was found that the device was fracture.

• Brand Name: FEMORAL IMPLANT IMPACTOR
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12415601
• MDR Text Key: 269821363
• Report Number: 1020279-2021-06689
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 00885556034156
• UDI-Public: 00885556034156
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

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: 71440005
• Device Catalogue Number: 71440005
• Device Lot Number: 17BM17536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/19/2021
• Initial Date FDA Received: 09/02/2021
• Supplement Dates Manufacturer Received: 09/08/2021
• Supplement Dates FDA Received: 09/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1