MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 52MM

Catalog Number 74122552

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Scar Tissue (2060)

Event Date 12/04/2014

Event Type  Injury  

Event Description

It was reported the patient had elevated metal iron levels, during revision it was found the inferior portion of the head had synovitis and granulomatous material.Cup kept in place, head explanted.

Manufacturer Narrative

Cup remained in place, primary part should be the head.Mdr updated to reflect this.

• Brand Name: HEMI HEAD 52MM
• Type of Device: HEMI HEAD 52MM
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 6147672
• MDR Text Key: 61533602
• Report Number: 3005975929-2016-00054
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2012
• Device Catalogue Number: 74122552
• Device Lot Number: 07KW14102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/12/2017; 01/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ANTHOLOGY HO POROUS SZ 6#71356106, LOT# 08AM14189; HEMI HEAD 52MM# 74122552, LOT# 07KW14102; MODULAR SLEEVE# 74222300, LOT# 08EW16969
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR