MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 COCR LINER 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFAC

Catalog Number 71341158

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Swelling (2091); Tissue Damage (2104); Toxicity (2333); Reaction (2414)

Event Date 07/29/2015

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to metallosis, fluid, tissue damage from metal debris and a soft tissue reaction.

• Brand Name: R3 COCR LINER 58MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFAC
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 5669219
• MDR Text Key: 45570497
• Report Number: 3005477969-2016-00118
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/05/2016

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: 01/31/2019
• Device Catalogue Number: 71341158
• Device Lot Number: 09AW20986
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/05/2016
• Initial Date FDA Received: 05/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/08/2016
• Date Device Manufactured: 02/19/2009
• 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: 66 YR