MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BIRMINGHAM HIP RESURFACING; BHR DYSPLASIA CUP 54MM

Catalog Number 74120254

Device Problems Material Disintegration (1177); Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Toxicity (2333); Injury (2348); Foreign Body In Patient (2687)

Event Date 09/21/2018

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to metallosis, pseudotumour and loosening.

Manufacturer Narrative

A modular head (74121446, 50645 sn 024), bhr dysplasia cup (74120254, 51246 sn 021), modular sleeve (details not visually confirmed batch unknown) and 48mm bhr dysplasiascrew (74500048, 05em08221) were received for investigation following right hip revision surgery due to metallosis, pseudotumour and loosening.Visual inspection was carried out on the returned devices.Fine scratches, scratch grooves and a wear patch were observed on the bearing surface of the head.Fine scratches were observed on the bearing surface of the dysplasia cup.Discolouration was noted on the internal taper of the sleeve.Wear analysis was performed to review linear wear on the bearing surface of the modular head and dysplasia cup.The wear image for the dysplasia cup shows the wear patch extending from the bearing surface to the edge of the cup.Roundness profile for the head showed the maximum linear wear was 18.98.For the dysplasia cup the maximum linear wear was 5.6¿m.For a combined head and cup maximum linear wear of 24.58¿m.The measured combined linear wear is 24.58 ¿m on the bearing surface.Based on historic wear data, after 12.1 years in vivo, the measured combined linear wear is in line with the expected wear for a non-edge loaded smith and nephew large diameter metal-on-metal device.The position of wear on the acetabular cup shows that the wear was extending from the bearing surface to the edge of the cup.The sleeve used for the modular head is a not a standard smith & nephew 12/14 sleeve.Wear on the internal taper was not measured due to lack of non-contact (reference) regions on the sleeve.No medical documents were received.Wear analyses of the explants show the wear is in line with the expected for a non-edge loaded large diameter metal-on-metal device; the position of wear on the acetabular cup shows that the wear was extending from the bearing surface of the cup.Without the supporting lab/pathology results, imaging, and/or operative reports, the root cause of the reported metallosis, pseudotumour, and loosening cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.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.No preventative or corrective action has been initiated as a result of this investigation.Devices have been retained at smith & nephew aurora, and are available for return if requested by the customer.

• Brand Name: BIRMINGHAM HIP RESURFACING
• Type of Device: BHR DYSPLASIA CUP 54MM
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, CV31 3HL; UK CV31 3HL
• MDR Report Key: 7968659
• MDR Text Key: 123799131
• Report Number: 3005975929-2018-00377
• Device Sequence Number: 0
• Product Code: NXT
• 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: 07/09/2019
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: 74120254
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2018
• Initial Date FDA Received: 10/16/2018
• Supplement Dates Manufacturer Received: 09/24/2018
• Supplement Dates FDA Received: 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL STEM, PART AND LOT # UNKNOWN; MODULAR HEAD, # 74222146, LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN; PART# 74121446, LOT# 50646; PART# 74500048, LOT# 05EM08221; FEMORAL STEM, PART AND LOT # UNKNOWN; MODULAR HEAD, # 74222146, LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention