MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR MODULAR HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74222146

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Foreign Body Reaction (1868); Metal Related Pathology (4530)

Event Date 07/18/2019

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

(b)(6) bilateral patient.It was reported that, after a primary r3-tha construct had been implanted on the plaintiff¿s left hip on (b)(6) 2009, the plaintiff experienced metallosis and a minor inflammatory process consistent with alval lesion.A revision surgery was performed on (b)(6) 2019 to treat this adverse event; the bhr modular head 46mm and r3 acetabular liner co-cr were explanted.The plaintiff was taken to recovery room in good condition.

Manufacturer Narrative

H3, h6: it was reported that a left hip revision surgery was performed.During the revision, the bhr modular head 46mm and r3 acetabular liner co-cr were explanted.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the modular head, liner, r3 shell, sleeve and stem 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, liner, shell and stem.Similar complaints were found for the sleeve.However, as the device is no longer sold, no action is to be taken.A review of the historical complaint data for the modular head, liner and sleeve was performed using related reported failures and the part number for the prior 12 months as of the complaint aware date.No other similar complaints have been identified for the sleeve.Similar complaints have been identified for the modular head and the r3 liner.However, as the device is no longer sold, no action is to be taken.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 upon release for distribution.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.Modular head, r3 liner, modular sleeve 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.The available medical documents were reviewed.With the information provided the clinical root cause of the aseptic, lymphocyte-dominated vasculitis-associated lesion cannot be confirmed and it cannot be concluded the reported clinical reaction was associated with a mal performance of the implant.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.Without the return of the actual devices or further information we cannot further investigate or confirm the reported complaint, or the details supplied in this 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 and preventative actions is not indicated.

• Brand Name: BHR MODULAR HEAD 46MM
• 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: 12519605
• MDR Text Key: 272921500
• Report Number: 3005975929-2021-00423
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010578709
• UDI-Public: 3596010578709
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2013
• Device Catalogue Number: 74222146
• Device Lot Number: 08MW20361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/31/2008
• 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; Other
• Patient Age: 46 YR