MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 COCR LINER 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71341160

Device Problems Corroded (1131); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/17/2016

Event Type  Injury  

Event Description

It was reported that bilateral revision surgery was performed due to pain.Corrosion at taper sleeve junction noted.Left hip.Right hip procedure reported via mdr 3005975929-2016-00004.

Manufacturer Narrative

Attached evaluation summary supplements previously provided evaluation summary.- attachment (b)(4).

• Brand Name: R3 COCR LINER 60MM
• 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: 5935549
• MDR Text Key: 54163229
• Report Number: 3005975929-2016-00005
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• 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: 71341160
• Device Lot Number: 08MW20574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2009
• 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, # 74122548, LOT # 10AW06322; MODULAR SLEEVE, # 74222400, LOT # 08AW15342
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 120