MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 46MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120146

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

Patient Problems Unspecified Infection (1930); Metal Related Pathology (4530)

Event Date 05/29/2021

Event Type  Injury  

Event Description

It was reported that, after a bhr tha was performed on (b)(6) 2008, the patient experienced infection and metallosis.A revision surgery was performed on (b)(6) 2021 to treat these adverse events.All the components were explanted.It is unknown if the patient received any medication to treat the infection.The patient outcome is unknown.

Manufacturer Narrative

It was reported that, following a bhr tha surgery, the patient experienced infection and metallosis.The devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.A review of the complaint history for the acetabular cup, modular head and sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for acetabular cup or modular head.Similar complaints have been identified for the sleeve.However, as the device is no longer sold, no action is to be taken.On account of the fact devices reportedly involved in this incident were not returned for evaluation, the relevant production records were reviewed.All released devices involved met manufacturing specifications upon release for distribution.It was also confirmed that all the devices were sterilised within normal parameters.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.No further actions are required at this time.Smith and nephew has not received the explanted device and/or adequate materials to perform a full clinical/medical evaluation.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Without return of the applicable devices or further information we cannot advance the investigation or confirm the details supplied in this complaint.Furthermore, our investigation remains inconclusive and a definitive root cause cannot be determined.Due to the insufficient information provided, we are unable to determine specific factors known to contribute to the alleged fault.If the devices or additional information become 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

H10: additional information in d4 and d9.

Manufacturer Narrative

H9: (b)(4).H3, h6.A bhr cup (74120146, 53771), bhr modular head (74222138, 07jw13641), bhr modular sleeve (74222200 08fw17503) and anthology stem (part and lot obscured) were received for investigation following hip revision surgery for infection and metallosis.The devices were used in treatment.A review of the historical complaints data for the bhr cup, bhr head, anthology stem and modular sleeve 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.No other complaints were identified to involve any of the device batches.No other similar complaints were identified for the part number and the reported/related failure mode for the cup, sleeve and stem.A similar complaint was found for the head.However, as the device is no longer sold, no action is to be taken.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.It was also confirmed that all devices were correctly sterilised.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 alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.A review of historic quality escalation actions related to the products and similar complaint events was performed.Prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible; no further escalation actions required.Visual inspection was carried out on the returned devices.A wear patch and patches of discolouration were observed on the modular head.Scratches were observed on the bearing surface of the bhr cup.Surface texture change and discolouration were observed on the internal sleeve taper.Minimal discolouration and surface texture change were observed on the external taper of the sleeve.Minimal discolouration and surface texture change were observed on the modular head taper.Discolouration was observed on the taper of the stem and damage was observed on the neck of the stem.Wear analysis was performed to review linear wear on the bearing surface of the modular head and bhr cup.The wear images identified a wear patch on the bearing surface for the bhr head, and a wear patch at the edge of the cup.Maximum linear wear for the bhr head was 125.0m.On the bhr cup maximum linear wear was 138.1m for a combined head & cup maximum linear wear of 263.1 m.Measurement of the vertical straightness profile of the internal sleeve taper showed material loss to a maximum depth of 63.84 m.Depth of material loss on the stem taper could not be measured with the measuring technique used due to a lack of non-contact (reference) region.Based on historic wear data, after 12.7 years in vivo, the measured combined linear wear is higher than the expected wear for a non-edge loaded smith and nephew large diameter metal-on-metal device.The position of wear on the acetabular cup shows that edge loading has occurred.Material loss was measured on the internal taper of the sleeve.The available medical documentation was reviewed.With the information provided the clinical root cause of the reported infection cannot be confirmed.Although additional clinical documentation was not provided, the product evaluation findings of surface texture change and discoloration on the internal sleeve taper and stem are consistent with findings associated with trunnionosis.It is unknown if the findings of edge loading led to trunnionosis, the reported metallosis and subsequent revision.The patient impact beyond the reported events cannot be determined.Based on the information provided and the returned device we can confirm the complaint.However, without additional information such as medical records or progressive x-rays, we cannot determine whether the devices were always misaligned, leading to the wear observed.Other specific factors that are known to contribute to the alleged fault are incorrect implantation angle or trauma to the joint replacement.No preventative or corrective action has been initiated as a result of this investigation.The devices will be retained.

• Brand Name: ACETLR CUP HAP 46MM 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: 12012574
• MDR Text Key: 256690290
• Report Number: 3005975929-2021-00316
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502544
• UDI-Public: 3596010502544
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/16/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2010
• Device Catalogue Number: 74120146
• Device Lot Number: 53771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/29/2021
• Initial Date FDA Received: 06/16/2021
• Supplement Dates Manufacturer Received: 10/29/2021; 06/20/2022; 12/15/2022
• Supplement Dates FDA Received: 11/01/2021; 06/20/2022; 12/16/2022
• 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: PLEASE REFER TO H10.
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other