MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2019

Event Type  Injury  

Event Description

It was reported that during surgery it was noticed that the required screws for completing the surgery were not available.Sales rep noticed the screws were not added in the initial purchase order so they were not delivered.No backup devices were available so the surgeon finished the surgery with a combination of several competitor products and a s&n stem.A delay of 10-15 minutes was reported.No patient injury or other complications were reported.

Manufacturer Narrative

It was reported that during surgery it was noticed that the required screws for completing the surgery were not available.Sales rep noticed the screws were not added in the initial purchase order.The affected complaint devices, intended to be used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Smith and nephew has been unable to obtain device details.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the devices failed to meet specifications.A relationship, if any, between the devices and the reported incident could not be corroborated.The user error is believed to be the root cause of this failure.The uk training team has been made aware of this issue.Based on this investigation, the need for corrective action is not indicated.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: HIP IMPLANT
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9356732
• MDR Text Key: 167431504
• Report Number: 1020279-2019-04124
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1