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

Catalog Number 71341152

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 07/16/2013

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to pain (beginning in (b)(6) 2012), weakness of the legs and hips, elevated cobalt and chromium levels and fluid accumulations around the hip.It was reported that following implantation, the patient's wounds healed without infection and that x-rays showed the hip replacement to be properly positioned, and that the devices suffered no impacts.

Manufacturer Narrative

The above combination of devices constitutes an off label application in the united states.

• 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; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: michael simmonds ; 4419264823
• MDR Report Key: 3603092
• MDR Text Key: 19801503
• Report Number: 3005477969-2014-00105
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 71341152
• Device Lot Number: 08MW20849
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACETABULAR SHELL, # 71335552, LOT # 09GM12930; SPHERICAL SCREW, # 71332525, LOT # 09ET32183; HEMI HEAD, # 74122540, LOT # 08FW17348; FEMORAL STEM, # 71309012, LOT # 09BM12706B; FEMORAL STEM, PART AND LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN; HEMI HEAD, PART AND LOT # UNKNOWN; ACETABULAR SHELL, PART AND LOT # UNKNOWN; MODULAR SLEEVE, # 74222200, LOT # 08GW17835; SPHERICAL SCREW, # 71332520, LOT # 08GM18251
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR