MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 42MM ID INTL COCR LINER 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71335854

Device Problem Insufficient Information (3190)

Patient Problems Toxicity (2333); Injury (2348)

Event Date 11/13/2017

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to elevated levels of cobalt and chromium.

Manufacturer Narrative

A bhmh (reported as 74222142, 08lw20144, part and lot obscured on returned item), r3 cocr liner (71335854, 08aw15260 029), and modular sleeve (reported as 74222100, lot 08hw18179, part and lot obscured on returned item) have been received following right hip revision reportedly due to elevated cobalt chrome levels.The r3 cup, spectron femoral hip stem, distal centralizer and hole cover were not returned and are believed to remain implanted.As of today, additional information has been requested for this revision complaint but has not become available.Production record review of the r3 cocr liner, bhmh head, modular sleeve, hole cover, spectron stem and distal centralizer did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.The production records could not be reviewed for the r3 shell due to lack of part & lot detail.Visual analysis identified a wear patch and a scratch on the bearing surface of the modular head, minimal discolouration and surface texture change on the taper of the r3 liner, and surface texture change and discolouration were observed on the internal sleeve taper.Wear analysis was performed to review linear wear on the bearing surface of the femoral head and r3 cocr liner and identified a wear patch on the bearing surface for the head, and wear on the liner, however the wear on the liner was low and within the manufacturing aberrations (wma) of the device.Maximum linear wear for the head was 13.6 m & wma on the liner.Volumetric wear was identified as 3.9 mm3 for the modular head and wma for the r3 cocr liner.Taper analysis for linear wear of the sleeve measured the maximum depth of material loss measured 13.6 m.Based on historic wear data, after 8.5 years in vivo, the measured linear wear for the head is in line with the expected wear for a head in a non-edge loaded smith and nephew large diameter metal-on-metal device.Wear of the r3 liner was low and within the manufacturing aberrations (wma).Material loss was measured on the internal taper of the sleeve.The provided copies of handwritten medical notes did not provide information to perform an assessment of the reported event; therefore, no thorough medical investigation and assessment of the reported complaint can be performed.Based on this investigation the root cause of the reported revision could not be determined conclusively.If additional information becomes available in the future, this case will be reopened.Without additional information about this patient's particular case, our investigation remains inconclusive.The affected r3 liner is no longer available on the market.No further preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: R3 42MM ID INTL 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
• MDR Report Key: 7024084
• MDR Text Key: 91777949
• Report Number: 3005975929-2017-00394
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 71335854
• Device Lot Number: 08AW15260
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/13/2017
• Initial Date FDA Received: 11/13/2017
• Supplement Dates Manufacturer Received: 11/13/2017
• Supplement Dates FDA Received: 09/04/2018
• Patient Sequence Number: 1
• Treatment: ACETABULAR SHELL, # 71331854, LOT # UNKNOWN; DISTAL CENTRALISER, # 71313102, LOT # 09BM06503; FEMORAL STEM, # 71312112, LOT # 09BT28490; HOLE COVER, # 71336500, LOT # 08MM09240; MODULAR HEAD, # 74222142, LOT # 08LW20144; MODULAR SLEEVE, # 74222100, LOT # 08HW18179; ACETABULAR SHELL, # 71331854, LOT # UNKNOWN; DISTAL CENTRALISER, # 71313102, LOT # 09BM06503; FEMORAL STEM, # 71312112, LOT # 09BT28490; HOLE COVER, # 71336500, LOT # 08MM09240; MODULAR HEAD, # 74222142, LOT # 08LW20144; MODULAR SLEEVE, # 74222100, LOT # 08HW18179
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR