MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 50MM; PRSTHSS,HIP,SMCNSTRND,UNCMNTD,MTLPLYMR,PRS

Catalog Number 71337650

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 11/27/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to uknown reasons.

Manufacturer Narrative

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

• Brand Name: R3 20 DEG XLPE ACET LNR 32MM X 50MM
• Type of Device: PRSTHSS,HIP,SMCNSTRND,UNCMNTD,MTLPLYMR,PRS
• 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 ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7140047
• MDR Text Key: 95550993
• Report Number: 1020279-2017-01329
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598486
• UDI-Public: 03596010598486
• Combination Product (y/n): N
• PMA/PMN Number: K070756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2022
• Device Catalogue Number: 71337650
• Device Lot Number: 12JM08170
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/14/2012
• 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