MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 44MM ID US COCR LNR 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number OR71341156

Device Problems Corroded (1131); Device Contamination with Chemical or Other Material (2944); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Toxicity (2333)

Event Date 02/05/2016

Event Type  Injury  

Event Description

Left hip revision surgery due to metallosis.It was reported there was a mall amount of corrosive debris around trunnion.

Manufacturer Narrative

[(b)(4)].

• Brand Name: R3 44MM ID US COCR LNR 56MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamingtong spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: claudia de santis ; scachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 6321542
• MDR Text Key: 67082619
• Report Number: 3005975929-2017-00030
• 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: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: OR71341156
• Device Lot Number: 088830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2017
• Date Device Manufactured: 01/09/2009
• 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: HEMI HEAD44MM#74122544, LOT#08GW18057; MODULAR SLEEVE -4MM 12/14#74222100, LOT#08JW19027; R3 3 HOLE ACET SHELL 56MM#71335556, LOT#09DM09882; REF SPHER HEAD SCREW 15MM#71332515, LOT#09EM20556; REF SPHER HEAD SCREW 20MM#71332520, LOT#09FT32428; REF THREADED HOLE COVER#71336500, LOT#09GM15908; SYN POR HO FEM COM SZ 12#71306112, LOT#09HM14139
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR