MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 46MM ID US COCR LNR 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71341158

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Pain (1994); Toxicity (2333); Fluid Discharge (2686)

Event Date 11/20/2014

Event Type  Injury  

Event Description

Customer reports two years of right hip pain, increased metal ion levels and mri showed fluid extending to the trochanteric bursa.Revision surgery performed.

Manufacturer Narrative

[(b)(4)].

• Brand Name: R3 46MM ID US COCR LNR 58MM
• 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; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 6013396
• MDR Text Key: 56925941
• Report Number: 3005975929-2016-00029
• 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,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• 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: 71341158
• Device Lot Number: 08MW20666
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2009
• 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 HEAD 74122546, LOT 08GW18084; MODULAR SLEEVE 74222400, LOT 9838A; R3 ACETABULAR SHELL 71335556, LOT 09BM03276
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR