MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71336456

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 03/27/2024

Event Type  Injury  

Manufacturer Narrative

Internal reference number: (b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.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 Description

It was reported that, after a thr had been performed on an unknow date, the patient experienced an infection.A revision surgery was performed on (b)(6) 2024 to address this adverse event.Patient's current health status is unknown.

• Brand Name: REF THREE HOLE SHELL 56MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19142493
• MDR Text Key: 340580054
• Report Number: 1020279-2024-00781
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010454379
• UDI-Public: 03596010454379
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K960094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2016
• Device Catalogue Number: 71336456
• Device Lot Number: 06EM03301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 71312362/CPCS COCR PRIM SO 12/14 SZ 2; 71332530/REF SPHER HEAD SCREW 30MM; 71332530/REF SPHER HEAD SCREW 30MM; 71333345/REF XLPE 36 20 DEG 54-56 F; 71343603/OXINIUM FEM HD 12/14 36 MM -3
• Patient Outcome(s): Required Intervention