MAUDE Adverse Event Report: SMITH & NEPHEW R3; COCR ACETABULAR LINER

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Muscle Weakness (1967); Pain (1994); Toxicity (2333)

Event Date 12/02/2013

Event Type  Injury  

Event Description

It was reported that revision surgery of the right hip was performed.Pain, weakness of the legs and hips, elevated cobalt and chromium levels, and fluid accumulations around the hip were reported.

Manufacturer Narrative

• Brand Name: R3
• Type of Device: COCR ACETABULAR LINER
• Manufacturer (Section D): SMITH & NEPHEW; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 4430012
• MDR Text Key: 16991513
• Report Number: 3005477969-2015-00014
• 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: Consumer,Company Representative,company representative
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2015
• Initial Date FDA Received: 01/19/2015
• Supplement Dates Manufacturer Received: 01/07/2015
• Supplement Dates FDA Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETABULAR SHELL, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN; ACETABULAR SHELL, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR