MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 48MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number 74122548

Device Problems Material Integrity Problem (2978); Patient Device Interaction Problem (4001)

Patient Problems Toxicity (2333); Test Result (2695)

Event Date 02/19/2018

Event Type  Injury  

Event Description

It was reported that revision surgery was performed.Surgeon reportedly suspected alval due to high metal ion levels.

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21cfr, part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.

• Brand Name: HEMI HEAD 48MM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 7291581
• MDR Text Key: 100757470
• Report Number: 3005975929-2018-00061
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00885556071847
• UDI-Public: 00885556071847
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

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: 06/30/2013
• Device Catalogue Number: 74122548
• Device Lot Number: 08FW17379
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/19/2018
• Initial Date FDA Received: 02/23/2018
• Supplement Dates Manufacturer Received: 02/19/2018
• Supplement Dates FDA Received: 01/30/2019
• Patient Sequence Number: 1
• Treatment: ACETABULAR CUP, # 74122154, LOT # 08FW17312; FEMORAL STEM, # 71356108, LOT # 08HM12081; MODULAR SLEEVE, # 74222200, LOT # 08AW15334; ACETABULAR CUP, # 74122154, LOT # 08FW17312; FEMORAL STEM, # 71356108, LOT # 08HM12081; MODULAR SLEEVE, # 74222200, LOT # 08AW15334
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR