MAUDE Adverse Event Report: SMITH & NEPHEW, INC.; OXINIUM FEMORAL HEAD

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/03/2016

Event Type  Injury  

Manufacturer Narrative

Customer indicated that there is no product/device to be returned for investigation analysis.

Event Description

It was reported an unspecified implant failure occurred.Implant was used with competitor's product.No revision surgery information has been reported.

Manufacturer Narrative

The associated complaint device was not returned.A visual inspection of the product could not confirm the stated failure without obtaining the actual device/ product.An investigation by our clinical team showed that it was reported an unspecified implant failure occurred when the oxinium femoral head was matched with an alumina acetabular insert from an unspecified manufacturer.No revision surgery information has been reported.It is reported that this combination has not been studied nor approval sought in any market.It is uncertain if the implanted device is dimensionally sufficient and appropriate with the implanted oxinium femoral head component.No clinical relevant information was provided to conduct a thorough analysis of the reported issue.No medical investigation can be performed at this time.This case can be re-evaluated upon receiving relevant clinical documents.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.

• Type of Device: OXINIUM FEMORAL HEAD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: yagna angirish ; 1450 brooks rd; memphis, TN 38116 ; 9013995009
• MDR Report Key: 5510565
• MDR Text Key: 40678812
• Report Number: 1020279-2016-00238
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other