MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD DYSPL CUP HAP 46MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74120246
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inadequate Osseointegration (2646); No Information (3190)
Date of Event	04/12/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that left hip revision surgery was performed due to unspecified 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.
Event or Problem Description
Revision surgery due to infection.
Event or Problem Description
It was reported that the patient underwent a left total hip arthroplasty (tha) on (b)(6) 2008 due to severe coxarthrosis.A nonunion of the major trochanter was identified, and on (b)(6) 2009, the patient underwent surgical intervention involving the implantation of an accord plate, cables, and bone allograft.Subsequently, on (b)(6) 2014, the patient presented with signs of superinfection.A two-stage revision was performed, with stage i surgery on (b)(6) 2014 and stage ii on (b)(6) 2015.Intraoperative findings included fibrosis, chronic inflammation, and erosive synovitis with prosthetic particles.Serratia marcescens was identified in cultures during the course of treatment.The implant components were replaced with a zimmer trabecular acetabular shell, trilogy liner, and biolox femoral head.No further complications have been reported.The current patient's health is unknown.

• Brand Name: DYSPL CUP HAP 46MM 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 CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: sarah freestone
• MDR Report Key: 8613118
• Report Number: 3005975929-2019-00207
• Device Sequence Number: 2472604
• Product Code: NXT
• UDI-Device Identifier: 03596010502650
• UDI-Public: 03596010502650
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: STNP040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2026

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
• Device Expiration Date: 10/31/2009
• Device Catalogue Number: 74120246
• Device Lot Number: 50066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 05/13/2019; 02/04/2026
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 09/25/2019; 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2004
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PAR 74121438, LOT 50131; PAR 74121438, LOT 50131
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female