MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RIGHT ANTEVERTED MODULAR NECK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	OR71352117
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Disorder (2373)
Date of Event	11/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is an approximation as only the year was communicated to us.
Event or Problem Description
It was reported that patient underwent a revision surgery due to instability.This was a revision of a right anteverted modular neck smf.Surgeon wanted to fix the problem by switching the anteverted neck for a retroverted neck but since this was no longer an option in surgeon's expected timeframe he had to remove the well fixed smf stem, and give this patient a revision hip stem.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached file for our results of investigation.(b)(4).

• Brand Name: RIGHT ANTEVERTED MODULAR NECK
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7069996
• Report Number: 1020279-2017-01157
• Device Sequence Number: 11014115
• Product Code: LPH
• UDI-Device Identifier: 03596010619563
• UDI-Public: 03596010619563
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2018

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 Expiration Date: 10/28/2021
• Device Catalogue Number: OR71352117
• Device Lot Number: 11KTM0002C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2017
• Supplement Date Received by Manufacturer: 11/21/2017
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SMF STEM WITH STIKTITE SZ 3, 71352503/(B)(4)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention