MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF INTERFIT THRD HOLE COVER; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71330001

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

Patient Problem Unspecified Infection (1930)

Event Date 11/24/2017

Event Type  Injury  

Event Description

It was reported that patient underwent revision surgery due to infection, which involved removal of all implants.

• Brand Name: REF INTERFIT THRD HOLE COVER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau; SZ 05001
• MDR Report Key: 7058458
• MDR Text Key: 92900120
• Report Number: 1020279-2017-01118
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010196590
• UDI-Public: 03596010196590
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2023
• Device Catalogue Number: 71330001
• Device Lot Number: 13AM18509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2013
• 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: ANTHOLOGY HO POR PL HA SZ 7/71357107/12CM17388; COCR 12/14 FEM HD 32 + 8/71303208/13CT29132; REF SPHER HEAD SCREW 25MM/71332525/13DM20055; REF SPHER HEAD SCREW 35MM/71332535/13KM12354; REF THREE HOLE SHELL 58MM/71336458/12LM00109; REF XLPE 32 20 DEG 58-60 G/71333336/13GM03556
• Patient Outcome(s): Hospitalization; Required Intervention