MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 40MM OXINIUM MODULAR HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number 71342340

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 12/19/2018

Event Type  Injury  

Event Description

It was reported recurrent left hip dislocation and greater trochanter fracture on (b)(6) 2018 and (b)(6) 2018.Open reduction performed to correct the problem.

Manufacturer Narrative

The devices, used in treatment were not returned for evaluation, reporting event could not be confirmed.A clinical evaluation was conducted and confirms patient sustained a greater trochanter fracture intraoperatively, during his fourth revision.It cannot be concluded that the reported open reduction internal fixations were associated with a mal-performance of the implant vs early ambulation a complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Factors and/or potential probable causes that could have contributed to the reported event include but are not limited to incorrect material specification, traumatic injury, and/or patient condition.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: 40MM OXINIUM MODULAR HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9171678
• MDR Text Key: 161688975
• Report Number: 1020279-2019-03604
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 00885556112410
• UDI-Public: 00885556112410
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71342340
• Device Catalogue Number: 71342340
• Date Manufacturer Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention