MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 60MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120160

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Hearing Impairment (1881); Pain (1994); Arthralgia (2355); Ambulation Difficulties (2544); Partial Hearing Loss (4472); Metal Related Pathology (4530)

Event Date 01/01/1901

Event Type  Injury  

Event Description

Mom.It was reported that, from (b)(6) 2020, the patient experiences pain, difficulty to walk, fatigue after small effort, decrease hearing in the left ear.Radiology conclusions from (b)(6) 2021 indicate periprosthetic bone demineralization at the femoral level in the left hip.Test results performed on (b)(6) 2021 confirm that the patient has elevated metal ion in blood.According to the specialist, a bilateral revision surgery needs to be performed as soon as possible.

Manufacturer Narrative

H3, h6: it was reported that, from may 2020, the patient experiences pain, difficulty to walk, fatigue after small effort, decrease hearing in the left ear.The devices were used in treatment.As of today, additional information has been requested for this complaint but has not become available.A review of the complaint history for the bhr head and bhr cup was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the bhr cup.Similar complaints have been identified for the bhr head and this will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Review of the product instructions for use found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The available medical documents were reviewed.The clinical information provided of the elevated metal ion levels of cobalt 16,40 ¿g/l, and chromium 12,60 ¿g/l, 242,30 nmol/l, and reported symptoms of pain, difficulty walking, fatigue after small effort and decreased hearing in the left ear 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.According to the specialist, a left hip revision surgery needs to be performed as soon as possible.The patient impact beyond that which has already been reported cannot be determined.Should any additional relevant, clinical information become available, the case will be re-evaluated.Without further information we cannot further investigate or confirm the details supplied in this complaint.The investigation remains inconclusive and a definitive root cause cannot be determined.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

Manufacturer Narrative

H3, h6: it was reported that surgery was performed on the patient¿s left hip.As of today, the implanted devices all of which were used in treatment remain implanted and therefore cannot be evaluated.Additional information has been requested for this complaint but has not become available.A review of the historical complaints data for the cup and head was performed.Using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product.No other similar complaints were identified for the cup.Similar complaints have been identified for the head and this will continue to be monitored.A search was also performed using part numbers, the reported failure modes and description summary to evaluate patterns of repeated failures or defects in a timeframe of 12 months prior to the date in which the incident was reported.Other similar complaints were identified for the head and cup.This will continue to be monitored.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed for the cup and head.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.The available medical information was reviewed.With the information provided the clinical root cause of the reported pain, difficulty to walk, fatigue after small effort, decrease hearing in the left ear, and ¿metallosis¿ cannot be confirmed.It cannot be concluded the reported events and clinical reactions are associated with a mal performance of the implant or implant failure.The patient impact cannot be determined; however, it is noted a revision has been recommended.Without additional information we cannot further investigate or confirm the reported complaint.The 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 the products or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective or preventative action is not indicated.

Manufacturer Narrative

H10: it was reported that surgery was performed on the patient¿s left hip.As of today the devices remain implanted in the patient and therefore cannot be returned for evaluation.Additional information has been requested for this complaint but has not become available.A review of the historical complaints data for the cup and head was performed.Using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product.No other similar complaints were identified for the cup.Similar complaints have been identified for the head and this will continue to be monitored.A search was also performed using part numbers, the reported failure modes and description summary to evaluate patterns of repeated failures or defects in a timeframe of 12 months prior to the date in which the incident was reported.Other similar complaints were identified for the head and cup.This will continue to be monitored.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A review of prior 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.A risk management review was performed for the cup and head.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.The available medical information was reviewed.With the information provided the clinical root cause of the reported pain, difficulty to walk, fatigue after small effort, decrease hearing in the left ear, and ¿metallosis¿ cannot be confirmed.It cannot be concluded the reported events and clinical reactions are associated with a mal performance of the implant or implant failure.The patient impact cannot be determined; however, it is noted a revision has been recommended.Without additional information we cannot further investigate or confirm the reported complaint.The 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 the products or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective or preventative action is not indicated.Internal complaint reference number: (b)(4).

• Brand Name: ACETLR CUP HAP 60MM W/ IMPTR
• 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: 11787160
• MDR Text Key: 249455954
• Report Number: 3005975929-2021-00205
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502612
• UDI-Public: 03596010502612
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2015
• Device Model Number: 74120160
• Device Catalogue Number: 74120160
• Device Lot Number: 10FW28678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2010
• 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): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 85 KG