MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 28MM +4; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	71342804
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to the consequences of his right hip replacement, still exhibiting a jump phenomenon that almost permanently invalidates and hinders overall recovery.
Additional Manufacturer Narrative
The device, intended for use in treatment, was not returned for evaluation.A photo was provided but the failure could not be confirmed.The explants remain assembled together.The device was manufactured in 2017.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Our clinical/medical team noted: review of the provided operative report did not reveal any information surrounding the reported ¿jump phenomenon¿, which resulted in the rt tha revision.Additionally, there was no details provided for the post-operative left hip lumbosciatalgia and pain.Without additional supporting relevant medical records, a thorough clinical assessment cannot be performed.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: OXINIUM FEM HD 12/14 28MM +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: 9315163
• Report Number: 1020279-2019-03993
• Device Sequence Number: 13593178
• Product Code: LZO
• UDI-Device Identifier: 03596010474162
• UDI-Public: 03596010474162
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2020

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 Model Number: 71342804
• Device Catalogue Number: 71342804
• Device Lot Number: 17MM01933
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 10/15/2020
• 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