MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMF STEM WITH STIKTITE SZ 4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71352504
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	07/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Right hip revision surgery was reported due to metallosis and pain.
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.- attachment: [264964 summary.Pdf].
Event or Problem Description
It was reported that after a right tha had been performed on (b)(6) 2013 with an r3/smf system due to coxarthrosis, the patient experienced periprosthetic pain and metallosis.A revision surgery was performed on (b)(6) 2018 to address this adverse event.Current health status is unknown.

• Brand Name: SMF STEM WITH STIKTITE SZ 4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; brooks road; 1450; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; brooks road; 1450; memphis TN 38116
• Manufacturer Contact: sarah freestone
• MDR Report Key: 9005699
• Report Number: 3005975929-2019-00328
• Device Sequence Number: 2478162
• Product Code: LPH
• UDI-Device Identifier: 03596010619600
• UDI-Public: 03596010619600
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K080625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/04/2023
• 2 Devices were Involved in the Event: 1 2

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 Model Number: 71352504
• Device Catalogue Number: 71352504
• Device Lot Number: 13CM06702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 09/09/2019; 02/06/2023; 02/06/2023
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 12/06/2019; 02/07/2023; 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0946-2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71335552 / LOT: 13HM09451.; 71335752 / LOT: 13HM18909.; 71343600 / LOT: 13EM15930.; 71352112 / LOT: 13ATM0025H.; FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male