MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS R3 ACETABULAR LINER 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL,

Catalog Number 71335860

Device Problem Insufficient Information (3190)

Patient Problem Toxicity (2333)

Event Date 09/07/2015

Event Type  Injury  

Manufacturer Narrative

Udi/di: undetermined.

Event Description

It was reported that revision surgery was performed due to increased cobalt and chromium levels.

Manufacturer Narrative

Event Description

The shell, hole cover and femoral stem remained implanted.The liner, head and sleeve were explanted.

• Brand Name: R3 ACETABULAR LINER 60MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL,
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS; 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, FL 5001 ; SZ 5001
• MDR Report Key: 5073680
• MDR Text Key: 25613596
• Report Number: 3005477969-2015-00254
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 71335860
• Device Lot Number: 08AW15515 015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2008
• 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
• Patient Age: 65 YR