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

Catalog Number	74122548
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Tissue Damage (2104); Toxicity (2333)
Date of Event	09/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that right hip revision surgery was performed due to metallosis.All components removed.
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, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 8381223
• Report Number: 3005975929-2019-00095
• Device Sequence Number: 1783770
• Product Code: NXT
• UDI-Device Identifier: 00885556071847
• UDI-Public: 00885556071847
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2019

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: No Information
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: 74122548
• Device Lot Number: 08FW17379
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 09/25/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACETABULAR LINER, # 71341160, LOT # 08FW17424; ACETABULAR SHELL, # 71335560, LOT # 08MM08213; FIXATION SCREW, # 71332525, LOT # 08LT25675; FIXATION SCREW, # 71332525, LOT # 09DT30796; MODULAR SLEEVE, # 74222200, LOT # 08CW16024; ACETABULAR LINER, # 71341160, LOT # 08FW17424; ACETABULAR SHELL, # 71335560, LOT # 08MM08213; FIXATION SCREW, # 71332525, LOT # 08LT25675; FIXATION SCREW, # 71332525, LOT # 09DT30796; MODULAR SLEEVE, # 74222200, LOT # 08CW16024
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 100