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.

Manufacturer Narrative

The associated complaint devices were not returned.The clinical/medical team concluded, it was reported that a revision was performed due to infection.However, there is no report of any lab tests confirming an infection.There were three attempts to obtain clinical/medical records to adequately perform a clinical assessment, however nothing has been provided.The patient impact beyond the revision surgery cannot be determined, as there is no report of the patient¿s current condition, infection status or how the procedure was tolerated.No further clinical assessment is warranted.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.Product was sterilized according to sterilization release documentation from quality control.Without the actual product involved and/or device information our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• 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: 7058459
• MDR Text Key: 92899621
• Report Number: 1020279-2017-01119
• 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,Followup
• Report Date: 04/10/2018

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 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
• Initial Date Manufacturer Received: 11/24/2017
• Initial Date FDA Received: 11/27/2017
• Supplement Dates Manufacturer Received: 11/24/2017
• Supplement Dates FDA Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: No
• 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