MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFAC

Model Number 74120152

Device Problems Metal Shedding Debris (1804); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 04/29/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that revision surgery of the right hip was performed due to failed prosthesis and metallosis.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to metallosis.During the revision the bhr head and bhr cup were removed.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 devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.The available medical documents were reviewed.According to the received surgical report, the implantation was performed successfully.No inconsistencies with respect of the reported revision are detectable.Review of the provided revision report indicates that the post-operative diagnosis was metallosis reaction causing significant osteolysis, synovitis and a moderate pseudotumor and neck thinning.No report of a histopathological analysis of the mentioned samples taken at the revision was available and further details about the nature of the intraoperative findings remains unknown.No relevant radiographs were received.Therefore, the position of the implant in situ and a possible change of it could not be evaluated.A root cause for the reported reasons of this revision cannot be determined.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

Us legal: it was reported that, after a right bhr due to degenerative joint disease, plaintiff experienced pain in both hips and knees, ultrasound confirm complex fluid collection in the right hip consistent with a pseudotumor, blood test confirmed chromium and cobalt elevated.Plaintiff underwent a revision surgery where was confirmed significant osteolysis, synovitis and it was require a bursectomy.Patient outcome is unknown.

• Brand Name: BHR ACETABULAR CUP 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFAC
• 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: claudia odoy ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 5569053
• MDR Text Key: 42414236
• Report Number: 3005477969-2016-00077
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502575
• UDI-Public: 03596010502575
• 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: Other,Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Model Number: 74120152
• Device Catalogue Number: 74120152
• Device Lot Number: 085955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2008
• 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: FEMORAL HEAD, # 74121146, LOT # 086253
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female