MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74121146

Device Problems Biocompatibility (2886); Insufficient Information (3190)

Patient Problems Infiltration into Tissue (1931); Insufficient Information (4580)

Event Date 11/25/2016

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, after right bhr on (b)(6) 2014, the medical providers have recommended a revision surgery.It is unknown whether or how the adverse event has been treated.The current health status of the patient is unknown.

Manufacturer Narrative

H3, h6: it was reported that following a primary right hip surgery, the medical providers have recommended a revision surgery; the outcomes of this recommendation are unknown.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.Since part/lot details were not received for investigation no thorough manufacturing record review or assessment of the reported event can be performed.If the products or additional information become available in the future, the tasks will be reopened and performed.However, the released devices would have met manufacturing specifications at the time of production.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.Medical documents or adequate materials to fully evaluate the complaint have not been received, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Without the return of the devices used in treatment or additional information we cannot advance the investigation or confirm this complaint; our investigation remains inconclusive, and 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.

Manufacturer Narrative

Section d1 and d4 were corrected.

Manufacturer Narrative

H3, h6.It was reported that, after right bhr on (b)(6) 2014, the medical providers have recommended a revision surgery.As of today, the implanted devices, which were all used in treatment, remain implanted in the patient and therefore cannot be evaluated.However, it is currently unclear if a revision surgery has already been conducted or scheduled.As no device batch numbers were provided for investigation for the acetabular cup /femoral head, a manufacturing record review, device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the acetabular cup /femoral head.A review of historical complaints data was performed using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.No other similar complaint has been identified for the part number and the reported failure mode for the femoral head.Other similar complaint has been identified for the part number and the reported failure mode for the acetabular cup.However, as the device is no longer sold, no action is to be taken.The =46mm bhr resurfacing system has been phased out from the market and as a result there is no live risk management file to review.Therefore, an evaluation of failure modes is not required.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 required.The available medical documents were reviewed.Without the supporting laboratory/pathology results imaging, and/or the explant the clinical root cause cannot be determined.It cannot be concluded that the clinical reactions are associated with a mal-performance of the implant.The patient impact beyond that which has already been reported cannot be determined.Based on the information provided we cannot confirm or further investigate the reported complaint, our investigation remains inconclusive, and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If additional information becomes available in the future, this case will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

Manufacturer Narrative

H3, h6: it was reported that, after right bhr on (b)(6) 2014, the medical providers have recommended a revision surgery.As of today, the implanted devices, which were all used in treatment, remain implanted in the patient and therefore cannot be evaluated.However, it is currently unclear if a revision surgery has already been conducted or scheduled.As no device batch numbers were provided for investigation for the devices, a manufacturing record review could not be performed.Similarly, a complete review of the historical complaints data cannot be performed.A review of historical complaints data was performed using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint update date.Other similar complaints have been identified for the part numbers and the reported failure mode.This will continue to be monitored via routine trending, however it should be noted that the device is no longer sold.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 required.Insufficient information was made available to determine the revision of ifu applicable to the device at the time of manufacturing.However, a review of current ifu was conducted, which 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.The available medical documents were reviewed.Based on the limited information provided, the clinical root cause of the elevated metal ions and revision recommendation cannot be determined and it cannot be concluded that it was associated with a mal-performance of the implant.The patient impact beyond that which has already been reported 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, 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.

• Brand Name: RESURFACING FEMORAL HEAD 46MM
• 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: 13087689
• MDR Text Key: 282775262
• Report Number: 3005975929-2021-00581
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502780
• UDI-Public: 03596010502780
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74121146
• Device Catalogue Number: 74121146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2023
• 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: A
• Removal/Correction Number: Z-2745-2015
• Patient Sequence Number: 1
• Patient Sex: Male