MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABLR CUP HAP 44MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74120144
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Toxicity (2333); Test Result (2695)
Date of Event	01/31/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that left hip revision surgery was performed due to metallosis and elevated levels of cobalt and chromium.
Additional Manufacturer Narrative
Section e corrected.Smith & nephew is submitting this report pursuant to the provisions of 21 cfr, 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.- attachment: [(b)(4) summary.Pdf].

• Brand Name: ACETABLR CUP HAP 44MM W/ IMPTR
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, CV313 HL; UK CV313HL
• MDR Report Key: 7873369
• Report Number: 3005975929-2018-00321
• Device Sequence Number: 14007741
• Product Code: NXT
• UDI-Device Identifier: 03596010502537
• UDI-Public: 03596010502537
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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: 06/30/2010
• Device Model Number: 74120144
• Device Catalogue Number: 74120144
• Device Lot Number: 51821
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 74121138/RESURFACING FEMORAL HEAD 38MM/58863.; 74121138/RESURFACING FEMORAL HEAD 38MM/58863
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR