MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD FEMORAL HEAD 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74122152
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Toxicity (2333)
Date of Event	12/28/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that left hip revision surgery was performed due to metallosis and pseudotumour.Fluid in joint, foreign body reaction noted during revision.
Additional Manufacturer Narrative
It was reported that left hip revision surgery was performed due to metallosis and psuedotumour.Fluid in joint, foreign body reaction noted during revision.During the revision the bhr head was removed.The bhr cup remains implanted.As of today, device return and additional information has been requested for this complaint but has not become available.The device batch/lot details have not been received therefor no thorough manufacturing record review and assessment of the reported event can be performed.The available medical documents were reviewed.According to the provided revision report, there was fluid in the joint, erosion of the femoral neck, almost pseudotumor-like tissue, some foreign body reaction and metallosis.The components were described as well positioned and stable integrated.Review of the provided implantation and revision report did not reveal any inconsistencies related to the surgical technique that could explain the revision.Results from the mentioned pathological analysis were not provided.It was noted that use of a competitor's (stryker) dual mobility liner, (djo) femoral stem and (biolox) femoral head devices were implanted with the bhr cup at the time of revision.This activity was performed contrary to the instructions for use of for bhr implants which states under its important medical information, "do not mix components from other manufacturers.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 or Problem Description
Bilateral patient.It was reported that left hip revision surgery was performed due to metallosis, elevated metal ion levels in blood and pseudotumor formation.Fluid in joint, foreign body reaction noted during revision.

• Brand Name: FEMORAL HEAD 44MM
• Common Device Name: 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: michael simmonds
• MDR Report Key: 7482330
• Report Number: 3005975929-2018-00146
• Device Sequence Number: 16542187
• Product Code: NXT
• UDI-Device Identifier: 03596010552280
• UDI-Public: 03596010552280
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/21/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/29/2013
• Device Model Number: 74122152
• Device Catalogue Number: 74123144
• Device Lot Number: 08DW16635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 04/18/2018; 10/11/2021; 02/15/2022
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 08/17/2018; 10/22/2021; 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 74122152/ACETABULAR CUP HAP SIZE 44/52/UNKNOWN.; FEMORAL HEAD, # 74123144, LOT # NI.; FEMORAL HEAD, # 74123144, LOT # NI
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female