MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74122552
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	04/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a left hip revision due to dramatic synovial fluid, pain and pseudotumor.
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 52MM
• 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: 9659113
• Report Number: 3005975929-2020-00025
• Device Sequence Number: 3675360
• Product Code: NXT
• UDI-Device Identifier: 00885556071694
• UDI-Public: 00885556071694
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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: No Information
• Device Expiration Date: 11/29/2013
• Device Model Number: 74122552
• Device Catalogue Number: 74122552
• Device Lot Number: 08LW20002
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 02/12/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACETABULAR CUP 74122158/ 10AW25642; ANTHOLOGY STEM 71356007/ 10AM01914; MODULAR SLEEVE 74222100/ 10CW25951; ACETABULAR CUP 74122158/ 10AW25642; ANTHOLOGY STEM 71356007/ 10AM01914; MODULAR SLEEVE 74222100/ 10CW25951
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR