MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120154

Device Problems Connection Problem (2900); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Injury (2348); Test Result (2695); No Code Available (3191)

Event Date 02/16/2018

Event Type  Injury  

Event Description

It was reported that revision surgery was performed.

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to pain and other complications.During the revision the hemi head, modular sleeve and bhr cup were removed.The femoral stem remained implanted.As of today, device return and additional information has been requested for this complaint but has not become available.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.The available medical documents were reviewed.Review of the provided implantation report did not reveal any inconsistencies related to the surgical technique that could explain the later revision.According to the provided revision report, the patient had increasing pain over the last two years.Intra-operative findings were black and reddish joint fluids, black synovitis and acetabular bone fistulas and blackening consistent with significant metallosis.There was bone loss, destruction and erosion at the acetabulum, lucency with a step-off of off up to 2-3 mm at parts of the cup, some soft tissue attached and loosening.There were further changes described at the trunnion.The cup could be removed easily, but it remains unclear whether the cup was grossly loose.No xrays were provided to assess the implant position.As the device was not available, potential changes consistent with the reported findings could not be identified.Therefore, further assessment of possible contributing factors or a possible root cause cannot be performed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or 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.

Event Description

It was reported that left hip revision surgery was performed due to pain and other complications.Metallosis and pseudotumour reportedly noted in operative notes.

Manufacturer Narrative

Smith + nephew is submitting this report pursuant to the provisions of 21cfr, part 803.This report may be based upon information which smith + nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith + nephew, or its employees, that the report constitutes an admission that the device, smith + nephew or its employees caused or contributed to the potential event described in this report.

• Brand Name: BHR ACETABULAR CUP 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: 7280121
• MDR Text Key: 100401690
• Report Number: 3005975929-2018-00059
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502582
• UDI-Public: 03596010502582
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: 74120154
• Device Lot Number: 089964
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL STEM# 71356102, LOT # 05EM12137; HEMI HEAD #74122546, LOT # 08DW16731; MODULAR SLEEVE # 74222300, LOT # 08BW15658
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR