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

Catalog Number	74122548
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Toxicity (2333); Test Result (2695)
Date of Event	02/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed.Surgeon reportedly suspected alval due to high metal ion levels.
Additional 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
• Common Device Name: 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
• Report Number: 3005975929-2018-00061
• Device Sequence Number: 956987
• Product Code: KWL
• UDI-Device Identifier: 00885556071847
• UDI-Public: 00885556071847
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: 74122548
• Device Lot Number: 08FW17379
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/19/2018
• Supplement Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 01/30/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR