MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 22 MM +4; PRSTHSIS,HIP,SMI-CONSTRAIED,METAL/CERAMIC/POLYMR,CMNTDORNON-POROUS,UNCMNTD

Catalog Number	71342204
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to hip dislocation.
Additional Manufacturer Narrative
The associated polarcup insert and oxinium femoral head were not returned for evaluation.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.The devices were manufactured in 2016.A review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A clinical evaluation noted that no clinical relevant documents were provided to conduct a thorough medical assessment.Thus, no medical assessment is warranted at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.There is no information that would suggest the implanted devices failed to meet specifications.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: OXINIUM FEM HD 12/14 22 MM +4
• Common Device Name: PRSTHSIS,HIP,SMI-CONSTRAIED,METAL/CERAMIC/POLYMR,CMNTDORNON-POROUS,UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7484526
• Report Number: 1020279-2018-00841
• Device Sequence Number: 1716670
• Product Code: LZO
• UDI-Device Identifier: 03596010488879
• UDI-Public: 03596010488879
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 03/08/2019

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 Expiration Date: 03/30/2026
• Device Catalogue Number: 71342204
• Device Lot Number: 16DM00443
• Initial Date Received by Manufacturer: 04/08/2018
• Supplement Date Received by Manufacturer: 04/08/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 03/08/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 75100407- B1613967 / 75100464 - B1613071; 75100407- B1613967 / 75100464 - B1613071
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 81 YR