MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TITANIUM MODULAR HEAD SLEEVE +0MM SHORT; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71344247

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 06/26/2018

Event Type  Injury  

Event Description

It was reported that patient had increased nickel, titanium and vanadium levels.No treatment has been given to patient.

Manufacturer Narrative

The associated synergy porous plus standard offset stem, modular head sleeve and r3 0 hole acetabular shell were not returned for evaluation.The devices were manufactured in 2010 and 2011.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.Without the return of the actual product involved, our investigation of this report is inconclusive.A clinical evaluation noted that no clinical relevant documents were provided to conduct a thorough medical assessment.No medical assessment is warranted at this time.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: TITANIUM MODULAR HEAD SLEEVE +0MM SHORT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8123223
• MDR Text Key: 129015899
• Report Number: 1020279-2018-02645
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 00885556022757
• UDI-Public: 00885556022757
• Combination Product (y/n): N
• PMA/PMN Number: K093363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2021
• Device Catalogue Number: 71344247
• Device Lot Number: 11AM11071
• Date Manufacturer Received: 11/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other