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); Infiltration into Tissue (1931); 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 acetabular level in the right 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 (b)(6) 2020, the patient has experienced pain, difficulty to walk, fatigue after small effort and decreased hearing in the left ear.Radiology conclusions from (b)(6) 2021 indicate periprosthetic bone demineralization at the acetabular level in the right hip.Test results performed on (b)(6) 2021 confirm that the patient has elevated metal ions in their blood.As of today, the devices, which were used in treatment, remain implanted in the patient and therefore cannot be evaluated.Additional information has been requested for this complaint but has not become available.A review of the complaint history for the bhr cup and bhr head 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 head or cup.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Non-conformance was identified for the castings inspection procedure paperwork for the bhr head.However, all supporting documents confirm that this was an acceptable product when released.Review of the product ifu 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.The available medical documents were reviewed.The clinical information provided of the elevated metal ion levels of cobalt and chromium 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 right 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 the details supplied in 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.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

It was reported that following a primary right hip surgery, the patient experienced pain, difficulty walking and decreased hearing in the left ear.No revision surgery has been reported.As of today, the devices, all of which were used in treatment remain implanted in the patient; and additional information has been requested for this complaint but has not become available.A review of the historical complaints data for the acetabular cup and the 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 of 12 months prior to the date in which the incident was reported.No other similar complaints were identified to involve this batch of acetabular cups nor this batch of femoral heads, another similar complaint has been identified for the part numbers and the reported failure mode in this timeframe, however, this relates to the same patient.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 manufacturing records did not reveal any waivers, concessions, manufacturing, or material abnormalities that could have contributed to this issue.Non-conformance was raised to address the missing casting¿s inspection paperwork for the femoral head.However, all supporting documents confirm that this was an acceptable product when released.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.The available medical documents were 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 surgery has been recommended.Without 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 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.

• 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: 11787207
• MDR Text Key: 249465298
• Report Number: 3005975929-2021-00207
• 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
• Report Date: 03/04/2022

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: 12/29/2016
• Device Model Number: 74120160
• Device Catalogue Number: 74120160
• Device Lot Number: 11HW17433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/31/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 85 KG