MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM HD 10/12 32MM +0 EXT; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Catalog Number 71341940

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2019

Event Type  malfunction  

Event Description

It was reported that revision surgery was performed due to dislocation.The femoral head was exchanged.

Manufacturer Narrative

The associated complaint devices were not returned.The medical investigation concluded that no clinically relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.The root cause of the dislocation was not identified and the outcome of the revision procedure was not reported.The patient impact beyond the reported revision could not be determined.Should patient specific clinical documentation become available in the future, the clinical/medical task may be re-evaluated.Without the actual product involved and/or device information, our investigation cannot proceed.If the devices or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: OXINIUM HD 10/12 32MM +0 EXT
• Type of Device: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8920516
• MDR Text Key: 155192821
• Report Number: 1020279-2019-03125
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00885556112441
• UDI-Public: 00885556112441
• Combination Product (y/n): N
• PMA/PMN Number: K110101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71341940
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention