MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 56/62; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74122162
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a bhr revision was performed for unknown reasons.
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: ACETABULAR CUP HAP SIZE 56/62
• 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: 9592107
• Report Number: 3005975929-2020-00017
• Device Sequence Number: 516650
• Product Code: NXT
• UDI-Device Identifier: 03596010552334
• UDI-Public: 03596010552334
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2020

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: Lay User/Patient
• Device Expiration Date: 01/31/2022
• Device Model Number: 74122162
• Device Catalogue Number: 74122162
• Device Lot Number: 17AW00097
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 04/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention