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
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that revision surgery was performed due to dislocation.The femoral head was exchanged.
Additional 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
• Common Device Name: 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
• Report Number: 1020279-2019-03125
• Device Sequence Number: 268947
• Product Code: LZO
• UDI-Device Identifier: 00885556112441
• UDI-Public: 00885556112441
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71341940
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 11/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention