MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 44/50; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74122150
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Metal Related Pathology (4530)
Date of Event	03/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
Us legal it was reported that, after left birmingham hip resurfacing surgery was performed on (b)(6) 2014 due to pain, stiffness, catching and decreased activity capabilities, the patient experienced pain, significant fluid collection around her posterior hip capsules, as well as significantly elevated chromium and cobalt ions.This adverse event was treated with a revision surgery on (b)(6) 2020, in which a dusky gray-appearing inflamed synovium was noticed.Patient's current health status is unknown.
Additional Manufacturer Narrative
H3, h6.It was reported that a left hip revision surgery was performed.As of today, device return has been requested for this complaint but has not become available.As no device batch numbers were provided for investigation for the acetabular cup and the 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.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.Other similar complaints have been identified for the part number and the reported failure mode.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.The clinical information provided, of the chromium 15.3 and cobalt 19, significant fluid collection, and dusky gray-appearing inflamed synovium may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure.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 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.
Additional Manufacturer Narrative
It was reported that a left hip revision surgery was performed.As of today, device return has been requested for this complaint but has not become available.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the acetabular cup and the 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.Other similar complaints have been identified for the part number and the reported failure mode for the acetabular cup.Other similar complaints have been identified for the part number and the reported failure mode for the femoral head.However, as the devices are no longer sold, no action is to be taken.As no device batch numbers were provided for investigation, manufacturing record review, and device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.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.The available medical documents were reviewed.The clinical information provided, of the chromium 15.3 and cobalt 19, significant fluid collection, and dusky gray-appearing inflamed synovium may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure.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 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: ACETABULAR CUP HAP SIZE 44/50
• Common Device Name: 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: 14102000
• Report Number: 3005975929-2022-00158
• Device Sequence Number: 11959372
• Product Code: NXT
• UDI-Device Identifier: 03596010552273
• UDI-Public: 03596010552273
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 74122150
• Device Catalogue Number: 74122150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 05/16/2022; 09/07/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 05/18/2022; 09/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2267-2018 & Z-2268-201
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Sex: Female