MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 22 MM +0; PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/POLYMER,CEMENTED OR NON-POROUS

Catalog Number	71342200
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to dislocation of r3 constrained liner.
Event or Problem Description
It was reported that a revision surgery was performed to change the liner due to dislocation.
Additional Manufacturer Narrative
The affected oxonium femoral head was returned and evaluated.It was reported that a revision was performed "several years" post implantation due to disassociation.There have been three unsuccessful attempts to obtain supporting medical documentation, and very limited complaint details have been provided.The patient impact beyond the revision surgery cannot be determined as there is no report of the patient¿s current condition or how the procedure was tolerated.No further clinical assessment can be performed.A lab analysis noted the visually identified scratches and gouges on the femoral head are consistent with damage likely caused by articulating contact with another metal component such as the shell.Eds analysis of the gouged surface area confirms the presence of titanium in the examined area.This is likely due to contact and transfer from another component.Additional scratches on the face and chamfer areas leading into the internal taper were also observed.These scratches were likely produced during removal/extraction of the head.No other damage was noted on the femoral head.A review of complaint history revealed no prior complaints for the listed batch of femoral head.A review of the manufacturing records did not reveal any deviations that could have caused or contributed to the reported incident.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: OXINIUM FEM HD 12/14 22 MM +0
• 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: 7140018
• Report Number: 1020279-2017-01324
• Device Sequence Number: 13725994
• Product Code: LZO
• UDI-Device Identifier: 03596010488862
• UDI-Public: 03596010488862
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2018

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 Catalogue Number: 71342200
• Device Lot Number: 13JM01317
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 12/06/2017; 12/06/2017
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 03/28/2018; 06/25/2018
• 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: Required Intervention