MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG +4 XLPE ACET LNR 32MM X 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71336654

Device Problem Off-Label Use (1494)

Patient Problem Injury (2348)

Event Date 03/22/2017

Event Type  Injury  

Event Description

It was reported that an incorrect liner implant was put in patient.Liner put in was a size 32mm, +4mm lateralized acetabular liner for a 54mm cup.When patient returned for surgery on (b)(6) 2017 it was recognized that the liner should have been a 36mm, +4 liner for a 54mm cup.The liner was changed in that surgical procedure to be the correct liner.

Manufacturer Narrative

The asssociated complained device was not returned for evaluation.Please see attached file for the results of our investigation.(b)(4).

• Brand Name: R3 0 DEG +4 XLPE ACET LNR 32MM X 54MM
• 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: robert rust ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 6486122
• MDR Text Key: 72561462
• Report Number: 1020279-2017-00258
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010622501
• UDI-Public: 03596010622501
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71336654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Hospitalization; Required Intervention