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

Catalog Number 71335854

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problem Foreign Body Reaction (1868)

Event Date 03/19/2012

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to an adverse reaction to metal debris.The acetabular shell, femoral stem and hole cover remain implanted.

Manufacturer Narrative

(b)(4).

• Brand Name: R3
• Type of Device: COCR ACETABULAR LINER
• Manufacturer (Section D): SMITH & NEPHEW; 1 kingmaker court; warwick technology park; warwick CV34 6WG; UK CV34 6WG
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS, LTD.; aurora house, spa park; harrison way; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: lindsay d'alessandro ; aurora house, spa park,; harrison way; leamington spa CV31 -3HL ; UK CV31 3HL ; 4419264823
• MDR Report Key: 3619062
• MDR Text Key: 4171156
• Report Number: 3005477969-2014-00154
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 71335854
• Device Lot Number: 08LW20234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2008
• 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
• Treatment: MODULARSLEEVE, # (B)(4), LOT # 09BW217919; HOLE COVER, # (B)(4), LOT # 09GM15911; ACETABULAR SHELL, # (B)(4), LOT # 08BM17545; FEMORAL STEM, # (B)(4), LOT # 09EM132836; MODULAR HEAD, # (B)(4), LOT # 09CW22572
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 48