MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 56MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURF

Model Number 74120156

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiomyopathy (1764); Bone Fracture(s) (1870); Hip Fracture (2349); Thromboembolism (2654); Metal Related Pathology (4530); Insufficient Information (4580)

Event Date 02/07/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

Us legal - bilateral patient.It was reported that the patient underwent a revision surgery of the left hip on (b)(6) 2020 due to elevated cobalt and chromium levels, pain, and metal debris.The primary left bhr surgery was performed on (b)(6) 2009.The patient underwent another revision surgery of the right hip on (b)(6) 2020.The patient died on (b)(6) 2021, due to a pulmonary thromboembolism.He also suffered cardiomyopathy and other systemic conditions.

Manufacturer Narrative

H3, h6.It was reported that a left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.Since part/lot details were not received for investigation no thorough manufacturing record review can be performed.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.No medical documents were received to investigate the reported clinical reactions.Based on the reported symptoms it cannot be concluded that the events/clinical reactions (elevated cobalt and chromium levels, pain, metal debris, and patient death due to pulmonary thromboembolism) were associated with a mal-performance of the implant.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 information provided, factors known to contribute to the alleged fault include excessive physical activity levels and loosening of the components.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

It was reported that two left hip revision surgeries were performed due to a pelvic fracture and bone erosion secondary to metallic debris.No devices were explanted during the first revision surgery; an internal fixation using a plating system from a competitor.A second revision surgery was performed for hardware removal and conversion to a total hip arthroplasty.The patient died on (b)(6) 2021, due to a pulmonary thromboembolism.He also suffered cardiomyopathy and other systemic conditions.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 device 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 acetabular cup, and this failure will continue to be monitored.In the absence of the actual device, the production records were reviewed for the device reportedly involved in this incident.The device 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, no prior applicable escalation actions were identified.The available medical documents were reviewed.The complex left pelvic fracture was related to the patients bicycle accident.The reported loosening of the acetabular component may be consistent with the reported ¿metallosis and erosive debris¿ and/or a result of the patients bicycle accident.The reported elevated metal ions, and intraoperative findings of a cyst and metal debris may be consistent with the reported metallosis; however, the clinical root cause of the reported clinical reactions cannot be determined.It is not known the impact of the previous fall as well as pelvic fracture had on the patient¿s hip and if it was a root cause that lead to increased metal ions.No clinical documentation was provided in relation to the reported cardiomyopathy, other systemic conditions, or patient death due to a pulmonary thromboembolism.With the limited information provided the clinical root cause of the reported cardiomyopathy, and other systemic conditions cannot be confirmed, and it cannot be concluded the cardiomyopathy, and other systemic conditions were associated with a mal performance of the implant.The patient's death, 9-months post revision, was reported as ¿due to a pulmonary thromboembolism.¿ it cannot be concluded the thromboembolism and subsequent patient death were related to a malperformance of the implant or implant failure.Based on the available information we can confirm the reported complaint.The root cause of the pelvic fracture can be attributed to the patient's bicycle accident.However without further information a root cause cannot be determined for the reported metallosis and associated other symptoms.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 the patient underwent a first revision surgery of the left hip on (b)(6) 2020 due to a pelvic fracture and evidence of bony erosions secondary to metallic debris process.The procedure consisted of an internal fixation using a plating system from a competitor.No devices were explanted during this revision surgery.Additionally, the patient underwent a second revision surgery of the same hip on (b)(6) 2020 for hardware removal and conversion to tha.Both bhr acetabular cup and femoral head were removed and replaced with a tha system from a competitor.The primary left bhr surgery was performed on (b)(6) 2009.The patient died on (b)(6) 2021, due to a pulmonary thromboembolism.He also suffered cardiomyopathy and other systemic conditions.

• Brand Name: ACETLR CUP HAP 56MM W/ IMPTR
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURF
• 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: 13242485
• MDR Text Key: 283742148
• Report Number: 3005975929-2022-00013
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502599
• UDI-Public: 03596010502599
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74120156
• Device Catalogue Number: 74120156
• Device Lot Number: 94811016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2022
• 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
• Patient Outcome(s): Death; Hospitalization; Required Intervention; Other
• Patient Age: 73 YR
• Patient Sex: Male