MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 32MM +8; PROSTHESIS, HIP,SEMI-, MTL/CERAMIC/POLYMER,CMNDORNON-POROUS, UNCMNTD

Model Number 71343208

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 12/04/2019

Event Type  Injury  

Event Description

It was reported that the patient had smith&nephew products in place since (b)(6) 2013 and was feeling uncomfortable and loosening of the cup.Revision surgery was performed and the cup and inner head were explanted.

Manufacturer Narrative

The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that it has been communicated that no clinical documents are available.Therefore, no thorough clinical assessment of the reported issue can be rendered.Should additional information be provided, the clinical/medical investigation task will be reopened.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes of this event could include poor surgical technique or device selection.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.

• Brand Name: OXINIUM FEM HD 12/14 32MM +8
• Type of Device: PROSTHESIS, HIP,SEMI-, MTL/CERAMIC/POLYMER,CMNDORNON-POROUS, UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9528903
• MDR Text Key: 173068113
• Report Number: 1020279-2019-04621
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03596010474230
• UDI-Public: 03596010474230
• 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: 04/23/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 71343208
• Device Catalogue Number: 71343208
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 04/13/2020
• Supplement Dates FDA Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention