MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM XL/+12; PRSTHSIS,HIP,SMI-CNSTRAIND,METAL/CRAMIC/POLYMR,CMNTDORNON-POROUS,UNCMNTD

Catalog Number	71343612
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/25/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to fracture.Femoral head and stem explanted and replaced.Delay of less than 30min reported.
Additional Manufacturer Narrative
It was reported that the patient has fractured his medial calcar and his femoral stem has subsided, all due to his size and bulk.This led to his revision and the oxinium femoral head and synergy porous high offset stem were removed.The devices were not made available for evaluation.Therefore products inspection could not be performed.However, device details were provided.Thus, a review of device history record and complaint history were performed.The review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of complaint history on the listed parts revealed no prior complaints with the same failure mode.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Our clinical evaluation could not performed at this time as no clinical supporting documents were provided to conduct a thorough assessment of the reported issue.However, based the ct that confirms the calcar fracture and the x-ray showed the stem subsidence.The patient body habitus as a likely contributing factor cannot be ruled out.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: OXINIUM FEM HD 12/14 36 MM XL/+12
• Common Device Name: PRSTHSIS,HIP,SMI-CNSTRAIND,METAL/CRAMIC/POLYMR,CMNTDORNON-POROUS,UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8075685
• Report Number: 1020279-2018-02506
• Device Sequence Number: 11344198
• Product Code: LZO
• UDI-Device Identifier: 03596010520449
• UDI-Public: 03596010520449
• 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: 2018
• 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): 05/03/2019

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: 02/06/2026
• Device Catalogue Number: 71343612
• Device Lot Number: 16BM06841
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 05/03/2019
• 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
• Patient Age: 51 YR
• Patient Weight: 185