MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 42MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121142

Device Problems Biocompatibility (2886); Migration (4003)

Patient Problems Pain (1994); Arthralgia (2355)

Event Date 10/18/2023

Event Type  Injury  

Manufacturer Narrative

Internal reference number: (b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.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.

Event Description

It was reported that the plaintiff underwent a right birmingham hip resurfacing on (b)(6) 2015 because the patient suffered a severe degenerative osteoarthritis in the right hip.The patient suffered progressive and debilitating hip pain secondary to metallosis.Clinical and radiographic revealed evidence of metallosis.This adverse event was treated by a revision surgery on (b)(6) 2023.During surgery, it was noticed that the acetabular component was well fixed to the underlaying bone.It had been medialized and appeared to be penetrating through the medial wall on the x-rays.The removal of this could potentially place the patient at risk of severe bone loss, so it was decided to leave the cup in place.Resurfacing femoral head 42mm was removed.S+n polar stem 1 lateral, a 42 mm dual mobility head and a 28+8 inner head were implanted.Patient was transferred to the recovery room in good condition.

Manufacturer Narrative

H6: medical device problem code.Section h3, h6: it was reported that a right hip revision surgery was performed due to progressive and debilitating hip pain and metallosis.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.A review of the historical complaints data for the alleged devices was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the head, but no other similar complaints have been identified for the cup.This will continue to be monitored via routine trending, however it should be noted that this device is no longer sold.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.The review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.The available medical documents were reviewed.The significantly medialized acetabular component and the penetration of the acetabular cup through the medial wall was noted to happen during the implantation of the acetabular cup: therefore a procedural variance is the clinical root cause.With the information provided the reported metallosis could not be confirmed.The acetabular cup orientation cannot be ruled out as a contributing factor to the reported clinical event/reactions.The patient impact is the revision and expected convalescence period.A possible root cause of the issue is the significantly medialized acetabular component and the penetration of the acetabular cup through the medial wall which occurred during the implantation of the acetabular cup.A root cause of the metallosis could not be concluded: specific factors known to contribute to the alleged metallosis are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated h6: health effect - clinical code and health effect - impact code.

• Brand Name: RESURFACING FEMORAL HEAD 42MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18681632
• MDR Text Key: 335073779
• Report Number: 3005975929-2024-00018
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502773
• UDI-Public: 3596010502773
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2019
• Device Catalogue Number: 74121142
• Device Lot Number: 097854C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 74120148/ACETLR CUP HAP 48MM W/ IMPTR
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female