MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. R3 3 HOLE ACET SHELL 52MM PRSTHSIS, HIP, SMI-CNSTRIND, UNCMNTD, MTL/PLMER, PR

Catalog Number 71335552

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Local Reaction (2035); Injury (2348)

Event Date 03/19/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery from the right hip was performed due to pain, adverse local tissue reaction, fluid build up.

• Brand Name: R3 3 HOLE ACET SHELL 52MM
• Type of Device: PRSTHSIS, HIP, SMI-CNSTRIND, UNCMNTD, MTL/PLMER, PR
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; spa park; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 1450 brooks road; 38116; memphis, TN ; 5123913905
• MDR Report Key: 8996105
• MDR Text Key: 157727976
• Report Number: 3005975929-2019-00327
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 03/11/2022
• Device Catalogue Number: 71335552
• Device Lot Number: 12CM08257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 09/11/2019 Patient Sequence Number: 1