MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X 54MM PRSTHSS, HP, SM-CNSTRND, NCMNTD, MTL/PLYMR, PRS

Model Number 71332754

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 01/21/2020

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to primary coxarthrosis.

• Brand Name: R3 0 DEG XLPE ACET LNR 36MM X 54MM
• Type of Device: PRSTHSS, HP, SM-CNSTRND, NCMNTD, MTL/PLYMR, 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: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038
• MDR Report Key: 9666694
• MDR Text Key: 177648441
• Report Number: 1020279-2020-00465
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010597991
• UDI-Public: 03596010597991
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 03/22/2020
• Device Model Number: 71332754
• Device Catalogue Number: 71332754
• Device Lot Number: 10CM16073
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/04/2020 Patient Sequence Number: 1