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 High Test Results (2457)

Patient Problems Test Result (2695); Patch Test, Abnormal Results Of (3166)

Event Date 10/20/2017

Event Type  Injury  

Event Description

It was reported that patient presents increased titanium level due to titanium is present in implanted components.Titanium level 3.64 (upper reference range per als (b)(6) ab is 2.96).

Manufacturer Narrative

The affected titanium modular head sleeve, synergy femoral component and r3 0 hole acetabular shell were not returned for evaluation.A clinical evaluation noted that without supporting clinical/medical documents a thorough investigation cannot be performed at this time.Our investigation including a review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.Without the return of the actual product involved, our investigation of this report is inconclusive.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: 8039640
• MDR Text Key: 126179928
• Report Number: 1020279-2018-02374
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/18/2021
• Device Catalogue Number: 71344247
• Device Lot Number: 11HT09597
• Date Manufacturer Received: 10/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other