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

Device Problem Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Hemorrhage/Bleeding (1888); Pain (1994); Swelling (2091); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Date 02/07/2014

Event Type  Injury  

Manufacturer Narrative

It has been established that this incident has previously been reported via a prior mdr 3005477969-2014-00178.Please disregard this redundant report.A follow up report for the incident will be submitted via mdr 3005477969-2014-00178.

Event Description

It was reported that revision surgery was performed.A swinging sensation, increasing ¿cracking¿ in the joint while walking up the stairs or uphill, increasing nose bleeds, drying of the skin, swelling of the lower limbs, back pain, reduced walking distance of 2km, boil in the groin, insomnia and uncertainty relating to memory reported.The femoral stem remains implanted.

• 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
• Manufacturer (Section G): SMITH & NEPHEW; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: michael simmonds ; 4419264823
• MDR Report Key: 3809616
• MDR Text Key: 11786359
• Report Number: 3005477969-2014-00326
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: ACETABULAR SHELL, PART AND LOT # UNKNOWN; FEMORAL STEM, PART AND LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN; MODULAR HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention