MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 38MM ID INTL COCR LINER 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71335850

Device Problem Naturally Worn (2988)

Patient Problems Toxicity (2333); Osteopenia/ Osteoporosis (2651)

Event Date 11/08/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to pseudotumour compressing the sciatic vein and calcar bone loss due to metalosis.The worst wear was between the taper sleeve and the modular head.Cup and stem retained.

• Brand Name: R3 38MM ID INTL COCR LINER 50MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 9427899
• MDR Text Key: 169800948
• Report Number: 3005975929-2019-00425
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

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 Expiration Date: 07/29/2012
• Device Catalogue Number: 71335850
• Device Lot Number: 08AW15253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 12/18/2020
• Supplement Dates FDA Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODULAR SLEEVE 74222100/08GW17831
• Patient Outcome(s): Hospitalization; Required Intervention