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

Catalog Number 74121146

Device Problems Biocompatibility (2886); Migration (4003)

Patient Problems Fall (1848); Hip Fracture (2349); Non-union Bone Fracture (2369); Inadequate Osseointegration (2646); Metal Related Pathology (4530)

Event Date 03/10/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, after a primary left bhr hip surgery was performed in (b)(6) 2008, the plaintiff¿s medical provider has recommended a revision surgery due to a metal related pathology, however, the plaintiff has not been medically cleared to undergo through the procedure.The plaintiff¿s right hip was already revised in (b)(6) 2021 (covered under case- (b)(4)).The current state of health of the patient is unknown.

Manufacturer Narrative

Sections a2, a3, b4, b7, d1, d3 and d4 were updated due to new information received.

Event Description

*us legal* bilateral patient.It was reported that, after a primary left bhr hip surgery was performed in (b)(6) 2008 due to degenerative arthritis, the plaintiff¿s medical provider has recommended a revision surgery due to a metal related pathology, however, the plaintiff has not been medically cleared to undergo through the procedure.The plaintiff¿s right hip was already revised in (b)(6) 2021 (covered under case-(b)(4)).The current state of health of the patient is unknown.

Manufacturer Narrative

H3, h6: it was reported that, after a primary left bhr hip surgery the medical provider has recommended a revision surgery due to a metal related pathology, however, the plaintiff has not been medically cleared to undergo through the procedure.As of today, the implanted devices, which were all used in treatment, remain implanted in the patient and therefore cannot be evaluated.A review of the historical complaints data for the acetabular cup and femoral head was performed using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and 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 complaints were identified to involve this batch.Other similar complaints have been identified for the part number and the reported failure mode, and this failure will continue to be monitored.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.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 required.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.Although it has been reported that a revision surgery due to a metal related pathology has been recommended by the patient¿s medical provider, no further information was provided for review.Without the supporting laboratory/pathology results and imaging the clinical root cause of the reported ¿metal related pathology¿ cannot be confirmed and it cannot be concluded that the reported events were associated with a malperformance of the implant.The patient impact beyond that which has already been reported cannot be determined.Should any additional, relevant clinical information be provided, the complaint would be re-assessed.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.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.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

H11: corrected information in h6 (health effect - clinical code and medical device problem code).

Manufacturer Narrative

H3, h6.It was reported that bilateral patient had a left hip revision surgery performed due to pain, aseptic loosening of the left hip acetabular cup with aseptic lymphocyte-dominant vasculitis-associated lesion reaction, bone erosion of the neck with subsidence of the femoral resurfacing component and an unhealed acetabular fracture after a fall.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 femoral head 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 device; however, as the device is no longer sold, no action is to be taken.In the absence of the actual device, the production records were reviewed for the device 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 product 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.It is unknown to what extent the patient¿s underlying diagnosis of avascular necrosis had on the reported events and intraoperative findings.The patient¿s fall cannot be ruled out as a contributing factor to the reported pain and loosening of the cup.The nonunion fracture 2 years later of the left acetabulum is related to the patient¿s fall and not the implant and could affect the orientation of the acetabular shell but cannot confirm based on provided information.The revision intraoperative findings as well as elevated metal ions may be consistent with findings associated with metal debris.However, based on the information provided, the root cause of the reported clinical symptoms cannot be confirmed, and it cannot be concluded that the reported reactions were associated with a mal-performance of the implant based on the available information we can confirm the reported complaint, however without further information our investigation remains inconclusive, and 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 device 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

Bilateral patient.It was reported that, after a primary left bhr hip surgery was performed in (b)(6) 2008 due to degenerative arthritis, the patient experienced pain, aseptic loosening of the left hip acetabular cup with alval reaction, bone erosion of the neck with subsidence of the femoral resurfacing component and an unhealed transverse acetabular fracture after a fall in (b)(6) 2020.A revision surgery was performed on (b)(6) 2022 to treat these adverse events.During this procedure, both resurfacing components were explanted and replaced with competitors¿ devices.Intraoperatively, a black synovial tissue was encountered upon entering the capsule.The posterior wall of the acetabulum was completely deficient with a complete pelvic discontinuity.The patient¿s outcome is unknown.

• 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: 12916472
• MDR Text Key: 281595770
• Report Number: 3005975929-2021-00551
• Device Sequence Number: 1
• Product Code: NXT
• 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: Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2012
• Device Catalogue Number: 74121146
• Device Lot Number: 080652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 94 KG