MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 COCR LINER 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number OR71341150

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

Patient Problems Failure of Implant (1924); Pain (1994); Toxicity (2333); Joint Disorder (2373); Tissue Breakdown (2681)

Event Date 10/06/2016

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to pain and metallosis.Stem left implanted.

Manufacturer Narrative

(b)(4).

• Brand Name: R3 COCR LINER 50MM
• 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: 6716603
• MDR Text Key: 80117290
• Report Number: 3005975929-2017-00211
• 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: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: OR71341150
• Device Catalogue Number: 71341150
• Device Lot Number: 08FW17382
• 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: 12/18/2008
• 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, # 71338664, LOT # 11EM04408; FEMORAL STEM, # 71306113, LOT # 10MM09351; HEMI HEAD, # 74122538, LOT # 08DW16747; SPHERICAL SCREW, # 71332535, LOT # 11FM05698; SPHERICAL SCREW, # 71332540, LOT # 11FT07927
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 94