MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN HO TRIAL NECK SZ 8-13; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71366508

Device Problem Component Missing (2306)

Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2020

Event Type  Injury  

Event Description

It was reported that during surgery the device was found missing.There was a delay below 30 minutes and no injury was reported.No backup device was available at the moment.The surgery was finished by using a standard trial stem and using the final implant.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that, a review of this complaint case revealed there were no patient injuries reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible probable cause could include but not limited to lost during transport or cleaning.Based on this investigation, the need for corrective action is not indicated.Should the device or 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: SYN HO TRIAL NECK SZ 8-13
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10293439
• MDR Text Key: 199439566
• Report Number: 1020279-2020-03321
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010199911
• UDI-Public: 03596010199911
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71366508
• Device Catalogue Number: 71366508
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/18/2020
• Supplement Dates Manufacturer Received: 08/03/2021
• Supplement Dates FDA Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention