MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 22 MM +4; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Catalog Number	71342204
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was needed due to a dislocation.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.The lab analysis concluded, this examination showed scratching of the oxinium femoral head.This examination also showed deformation, discoloration, and impingement of the polyethylene of the r3 constrained liner as well as burnishing and fracture of the outer ring.The scratching of the oxinium femoral head was likely due to dislocation and explantation.The deformation of the locking region of the polyethylene of the r3 constrained liner was likely due to explantation.The discoloration of the polyethylene of the r3 constrained liner was likely due to absorbed biological fluid.The impingement was likely due to contact by the femoral hip stem neck.The burnishing and fracture of the outer ring were also likely due to the impingement of the femoral hip stem neck.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/failure mode.The clinical/medical team concluded, based on the product evaluation a probable dislocation occurred.However, without the requested clinical information i.E.X-rays and medical documents, the root cause of the reported dislocation cannot be determined.The future impact to the patient beyond the revision cannot be determined.Therefore, no further clinical /medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: OXINIUM FEM HD 12/14 22 MM +4
• 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: 8624637
• Report Number: 1020279-2019-01979
• Device Sequence Number: 19397621
• Product Code: LZO
• UDI-Device Identifier: 03596010488879
• UDI-Public: 03596010488879
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2019

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: 71342204
• Initial Date Received by Manufacturer: 04/27/2019
• Supplement Date Received by Manufacturer: 04/27/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 10/21/2019
• 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