MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR MODULAR HEAD 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74222144

Device Problems Material Disintegration (1177); Biocompatibility (2886)

Patient Problem Metal Related Pathology (4530)

Event Date 10/21/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

It was reported that, after thr (spectron modular birmingham) surgery had been performed on (b)(6) 2010, the patient experienced mom symptoms.This adverse event will be solved via planned revision surgery.Current health status of patient is unknown.

Event Description

It was reported that, after a bhr-tha construct had been implanted on (b)(6) 2010, the patient experienced mom symptoms.This adverse event will be solved via planned revision surgery as patient is on three-month waitlist.The bhr cup will be retained, so a dm liner was requested for conversion to tha.The spectron stem will also be retained.The bhr modular head and sleeve will be explanted in the conversion to tha.Current health status of patient is unknown.

Manufacturer Narrative

H10.Additional information in b5, d1, d4, g4, h4 and h6 (medical device problem code was updated).Internal reference number: (b)(4).

Manufacturer Narrative

H3, h6: it was reported that, after a bhr-tha construct had been implanted, the patient experienced mom symptoms.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation as they remain implanted within the patient.A review of the historical complaints data for the cup, head and modular sleeve 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, head or modular sleeve.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.No other similar complaints were identified for the modular sleeve.Other similar complaints have been identified for the cup and head.However, as these devices are no longer sold, no action is to be taken.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.Review of the product instructions for use found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was not performed for the cup and head as these devices have 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.The review concluded that previous events were identified and initiated, however there is not enough information to relate this event with prior escalated actions.Smith and nephew has not received adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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.

• Brand Name: BHR MODULAR HEAD 44MM
• 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: 12799873
• MDR Text Key: 280751626
• Report Number: 3005975929-2021-00527
• Device Sequence Number: 1
• Product Code: NXT
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• Device Catalogue Number: 74222144
• Device Lot Number: 09EW23458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/31/2009
• 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