MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR MODULAR HEAD 40MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74222140

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Foreign Body Reaction (1868); Failure of Implant (1924); Inflammation (1932); Metal Related Pathology (4530)

Event Date 07/18/2019

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

''(b)(6) legal'': bilateral patient.It was reported that, after a primary r3-tha construct had been implanted on the plaintiff¿s right hip on (b)(6) 2010, the plaintiff experienced metallosis, pseudotumor formation, an inflammatory process consistent with alval lesion and loosening of the acetabular cup implant.A revision surgery was performed on (b)(6) 2019 to treat this adverse event; the bhr modular head 40mm, r3 acetabular liner co-cr and r3 three hole hemispherical stiktite coated shell 52mm were explanted.The plaintiff was taken to recovery room in good condition.

Manufacturer Narrative

H3, h6: it was reported that right hip revision surgery was performed.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 historical complaints data for the modular head, sleeve and r3 liner 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 prior 12 months as of the complaint aware date.No other similar complaints have been identified for the liner to involve this batch.Other similar complaints were identified for the modular head and sleeve to involve this batch.However, as the devices are no longer sold, no action is to be taken.No other similar complaints have been identified for the modular head, sleeve and liner for the part number and the reported failure mode.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing, or material abnormalities that could have contributed to this issue.All the released devices involved met manufacturing specifications upon release for distribution.Review of the known devices ifu found adequate warnings and precautions in relation to the alleged failure modes.Modular heads, sleeves and r3 liners 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.The reported ¿aseptic lymphocyte-dominant vasculitis-associated lesions and intraoperative finding of a polylobed brownish mass with a grayish liquid, and unsealing of the cup, which can be seen as a result of metallosis, but the loosening and/or ¿completely reversed¿ cup could also accelerate wear and lead to metal debris and result in metallosis.Without the supporting laboratory/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported aseptic lymphocyte-dominant vasculitis-associated lesions, and pseudotumor cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.It is noted the patient had a second revision 15 months later.Without the return of the actual devices or 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.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 40MM
• 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: 12519264
• MDR Text Key: 272907644
• Report Number: 3005975929-2021-00419
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552457
• UDI-Public: 3596010552457
• 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: 01/19/2022

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: 09/30/2013
• Device Catalogue Number: 74222140
• Device Lot Number: 08JW19089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/30/2008
• 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