MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 32MM +4; ABSORBER, CARBON-DIOXIDE

Catalog Number 71343204

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 12/10/2018

Event Type  Injury  

Event Description

Revision surgery was performed due to postoperative bone fracture.

Manufacturer Narrative

The associated complaint devices were not returned.A clinical evaluation was conducted and no clinical relevant documents were provided to conduct a thorough medical assessment.No medical assessment is warranted at this time.This complaint will be re-evaluated if more information becomes available.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.We consider this investigation closed.

• Brand Name: OXINIUM FEM HD 12/14 32MM +4
• Type of Device: ABSORBER, CARBON-DIOXIDE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8233305
• MDR Text Key: 132591438
• Report Number: 1020279-2019-00102
• Device Sequence Number: 1
• Product Code: BSF
• UDI-Device Identifier: 03596010474223
• UDI-Public: 03596010474223
• Combination Product (y/n): N
• PMA/PMN Number: K021673
• 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: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71343204
• Device Lot Number: 18HM00686
• Date Manufacturer Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71339548_18FM1476971338663_18EM23226
• Patient Outcome(s): Hospitalization; Required Intervention