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

Catalog Number 74121142

Device Problems Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Complaint reference number: (b)(4).

Event Description

It was reported that, after a bhr system had been implanted on an unspecified date, the plaintiff experienced an unspecified adverse event that was addressed via revision surgery which was scheduled on (b)(6) 2023.No additional information was provided.

Manufacturer Narrative

It was reported that a revision surgery was performed due to an unspecified adverse event.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, or definite escalation actions review could not be performed.A review of the product¿s instructions for use was not possible due to limited information about the details of the event and device.Without basic part details or an alleged failure mode, no risk file review is possible.No further actions are required at this time.If more information is received, this investigation will be reopened.The requested supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the unspecified complications.With the limited information provided, the patient impact beyond the reported revision cannot be determined.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.A definitive root cause cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.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.

Event Description

It was reported that, after right hip resurfacing (bhr) was performed on (b)(6) 2015 due to osteoarthritis, the patient experienced femoral head loosening.This event was treated by performing a revision surgery on (b)(6) 2023, in which even though the acetabular cup was well-fixed, both resurfacing components were explanted, and a competitor¿s hip system (depuy) was placed in exchange.Minimal bone loss was caused with removal of the bhr acetabular component.Inferior and posterior specimens were collected from three different sites and were sent off for culture; however, tests results are not available at this time.Patient¿s current health status is unknown.

Manufacturer Narrative

Additional information: a2, b5, b7, d1, d4, d6a, h4, h6 g2.

Manufacturer Narrative

H9: the concomitant product 74120148 / lot# 14ew05886 was also bounded to an action reported to fda.Reference number would be: (b)(4).H3, h6.It was reported that, after right hip resurfacing (bhr) was performed due to osteoarthritis, the patient experienced femoral head loosening.This event was treated by performing a revision surgery in which even though the acetabular cup was well-fixed, both resurfacing components were explanted, and a competitor¿s hip system was placed in exchange.Patient¿s current health status is unknown.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 devices concerned 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 and 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 reported pain may be consistent with the loosened femoral component, scar tissue, and/or the heterotopic bone.With the information provided the clinical root cause of the reported femoral loosening cannot be confirmed.The scar tissue and heterotopic bone are known risk factors of hip surgery and are related to the surgical procedure and not the device.It cannot be concluded the reported clinical reactions/events were associated with a mal performance of the implant or implant failure.The patient impact beyond the reported revision cannot be determined.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.A definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement.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.

• 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: 16935744
• MDR Text Key: 315267379
• Report Number: 3005975929-2023-00073
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2019
• Device Catalogue Number: 74121142
• Device Lot Number: 095557A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2745-2015
• Patient Sequence Number: 1
• Treatment: 74120148/ACETLR CUP HAP 48MM W/ IMPTR.
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female