MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 COCR LINER 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71341154

Device Problems Material Fragmentation (1261); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Necrosis (1971); Pain (1994); Toxicity (2333); Device Embedded In Tissue or Plaque (3165)

Event Date 03/25/2016

Event Type  Injury  

Event Description

Left hip revision surgery was performed due to pain and elevated ion levels.Metal debris noted in joint space, appearance of bone necrosis.

Manufacturer Narrative

(b)(4).

• Brand Name: R3 COCR LINER 54MM
• 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: markus poettker ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6696363
• MDR Text Key: 79351944
• Report Number: 3005975929-2017-00199
• 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
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• 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: 71341154
• Device Lot Number: 08MW20432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2008
• 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, # 71335554, LOT # 08MM10361; FEMORAL STEM, # 71309014, LOT # 09DM04460A; HEMI HEAD, # 74122542, LOT # 08MW20373; MODULAR SLEEVE, # 74222100, LOT # 08GW17828; SPHERICAL SCREW, # 71332520, LOT # 09DT30972; SPHERICAL SCREW, # 71332520, LOT # 09FT32428
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR