MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 22 MM +8; PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/POLYMER,CEMENTED OR NON-POROUS

Catalog Number	71342208
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery due to multiple dislocations following primary hip arthroplasty.Surgeon found r3 cup stable and well fixed.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, based on the limited information provided, the root cause of the traumatic dislocation cannot be determined; however, the lateralized stem, probable gross instability, and dislocation were contributing factors to the (3rd) right tha revision.The patient impact beyond the probable pain and revision procedure itself cannot be concluded.No further medical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.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.

• Brand Name: OXINIUM FEM HD 12/14 22 MM +8
• Common Device Name: PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/POLYMER,CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7281021
• Report Number: 1020279-2018-00203
• Device Sequence Number: 19171160
• Product Code: LZO
• UDI-Device Identifier: 03596010488886
• UDI-Public: 03596010488886
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2018

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 Expiration Date: 07/20/2023
• Device Catalogue Number: 71342208
• Device Lot Number: 13GM14441
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2018
• Supplement Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 02/19/2018
• Supplement Report FDA Received Date: 05/03/2018
• 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