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

Catalog Number 71341150

Device Problems Device Slipped (1584); Malposition of Device (2616)

Patient Problems Necrosis (1971); Pain (1994); Toxicity (2333)

Event Date 11/18/2010

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to pain, loosening and displacement of the prosthetic joint, metallosis, and necrosis of the tissue at the implant site.

Event Description

A trochanteric bursal cyst was excised during the revision procedure, along with metal debris within the joint.

Manufacturer Narrative

(b)(4).

• Brand Name: R3
• Type of Device: COCR ACETABULAR LINER
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house spa park; harrison way; leamingon spa CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 3842409
• MDR Text Key: 4408453
• Report Number: 3005477969-2014-00346
• 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,company representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 71341150
• Device Lot Number: 09BW22121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2009
• 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: MODULAR SLEEVE, # (B)(4), LOT # 08FW17502; ACETABULAR SHELL, PART AND LOT NUMBERS UNKNOWN; HEMI HEAD, # (B)(4), LOT # 08JW19018; ACETABULAR SHELL, # (B)(4), LOT # 09CM18421; FEMORAL STEM, # (B)(4), LOT # 09BM09636
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR