MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEFT FEMORAL STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 0139204

Device Problem Connection Problem (2900)

Patient Problem Failure of Implant (1924)

Event Date 09/20/2022

Event Type  Injury  

Event Description

This is an adult male who presented to the emergency department for evaluation of left hip pain.Patient stated he has had both hips replaced and he was standing at his island eating a bowl of cereal around midnight when it felt like his left hip went out of socket and he collapsed to the floor.The patient states that he then crawled back to bed and was able to sleep however he had a great deal of discomfort in his left hip they kept waking him up.Prior to this he had no prior traumas or preceding pain.His previous left hip replacement was via posterior approach almost 10 years ago.

• Brand Name: LEFT FEMORAL STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 7135 goodlett farms parkway; cordova TN 38016
• MDR Report Key: 16409731
• MDR Text Key: 309898129
• Report Number: 16409731
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 0139204
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/17/2022
• Device Age: 18 YR
• Event Location: Home
• Date Report to Manufacturer: 02/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 21535 DA
• Patient Sex: Male
• Patient Weight: 127 KG
• Patient Race: White