MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BIRMINGHAM HIP RESURFACING; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122150

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Tissue Damage (2104); Toxicity (2333); Injury (2348)

Event Date 10/12/2018

Event Type  Injury  

Event Description

The surgeon reported advanced metallosis with bone destruction by metal on metal large head pairing.

Manufacturer Narrative

As of today, device return and additional information has been requested for this complaint but has not become available.Since neither the underlying medical documents nor device part details were received for investigation no thorough medical investigation, manufacturing record review and assessment of the reported event can be performed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient¿s particular case, our investigation remains inconclusive.No preventative or corrective action has been initiated as a result of this investigation.

Manufacturer Narrative

A modular head (details not visually confirmed), sleeve (details not visually confirmed) and bhr cup (74122150, 08ew16951 sn(b)(4)) were received for investigation following hip revision surgery for advanced metallosis with bone destruction.The production records were reviewed for the cup reportedly involved in this incident.A documentation review could not be completed for the modular head or sleeve as no details were provided.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.Visual inspection was carried out on the returned devices.Fine scratches, a wear patch and surface discolouration were observed on the bearing surface of the head.Fine scratches, damage on the rim and visual evidence of edge wear was observed on the bhr cup.Surface texture changes and discolouration were observed on the internal sleeve taper.Wear analysis was performed to review linear wear on the bearing surface of the modular head and bhr cup.The wear images identify a wear patch on the bearing surface of the head and a wear patch on the bhr cup that indicates edge loading.The maximum linear wear for the head was 417.3 m.The maximum linear wear for the bhr cup was 533.2 m.The combined maximum linear wear for the head and bhr cup was 950.5 m.Measurement of the vertical straightness profile of the internal sleeve taper showed material loss to a maximum depth of 38.3 m.The measured combined linear wear is 950.5 m on the bearing surface.Time in vivo is unknown, however, based on historical wear data, the combined linear wear for this device is higher than any non-edge loaded smith and nephew large diameter metal-on-metal device measured up to date.The position of wear on the acetabular cup shows that edge loading has occurred.Material loss was measured on the internal taper of the sleeve.No medical records were received for review.The explants were returned for analysis, and the analysis showed that edge loading of the acetabular cup has occurred.Material loss was also measured on the internal taper of the sleeve.Without additional information about the patient, the surgeries and x-rays to assess the implant fixation and position, further investigation and description of the reported findings cannot be performed.However, the demonstrated edge loading can result in higher rates of wear and metal debris which can be from incorrect positioning of the cup.This positioning cannot be concluded, and it cannot be determined if the cup migrated from implantation position vs error in implantation position.Based on this investigation the root cause of the reported revision could not be determined conclusively.However, the position of the wear indicates that edge loading has occurred, which could explain the wear observed.If additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.The devices will be retained and are available for return upon request.

• Brand Name: BIRMINGHAM HIP RESURFACING
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV313 HL; UK CV313HL
• MDR Report Key: 8063452
• MDR Text Key: 126918488
• Report Number: 3005975929-2018-00444
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552273
• UDI-Public: 03596010552273
• 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,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2013
• Device Catalogue Number: 74122150
• Device Lot Number: 08EW16951
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BHR MODULAR HEAD 44MM 74222144; FEMORAL HEAD, PART AND LOT # UNKNOWN; MODULAR SLEEVE 74222200/UNKNOWN; PLUS POLARSTEM 75002072; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention