MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71332758

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 09/06/2015

Event Type  Injury  

Event Description

It was reported the patient presented with a preoperative diagnosis of infected left total hip arthroplasty.The patient underwent an irrigation and debridement left total hip arthroplasty with exchange of modular components.

Manufacturer Narrative

The associated complaint device was not returned for evaluation.

• Brand Name: R3 0 DEG XLPE ACET LNR 36MM X 58MM
• 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: 6765092
• MDR Text Key: 81776118
• Report Number: 1020279-2017-00587
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598011
• UDI-Public: 03596010598011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 11/16/2017

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 Catalogue Number: 71332758
• Device Lot Number: 15DM11595
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2017
• Initial Date FDA Received: 08/03/2017
• Supplement Dates Manufacturer Received: 07/06/2017
• Supplement Dates FDA Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/17/2015
• 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
• Patient Age: 33 YR