MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 COCR LINER 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL

Catalog Number 71335854

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Necrosis (1971); Swelling (2091); Toxicity (2333)

Event Date 04/05/2016

Event Type  Injury  

Event Description

It was reported that a two stage revision surgery was scheduled due to metallosis / pseudotumor and tissue necrosis.Initial stage involved irrigation and debridement to remove extensive necrotic tissue.Devices will be removed and replaced during second stage procedure (date unconfirmed).

• Brand Name: R3 COCR LINER 54MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL
• 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: 5576513
• MDR Text Key: 42655508
• Report Number: 3005477969-2016-00080
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 71335854
• Device Lot Number: 08JW18739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2008
• 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