MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR MODULAR HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74222150

Device Problem Biocompatibility (2886)

Patient Problems Wound Dehiscence (1154); Necrosis (1971); Dizziness (2194); Discomfort (2330); Ambulation Difficulties (2544); Metal Related Pathology (4530)

Event Date 05/16/2017

Event Type  Injury  

Manufacturer Narrative

Internal reference number: case (b)(4).

Event Description

(b)(6) legal.It was reported that, after a primary bhr resurfacing construct had been implanted on the plaintiff¿s right hip on (b)(6) 2007, the plaintiff experienced metallosis, elevated serum chromium and cobalt levels, pain, loss of balance, dizziness, ambulatory difficulties, tissue dehiscence and necrosis, bone necrosis, hypertrophic scarring and lumbar strain.A revision surgery was performed on (b)(6) 2017 to treat this adverse event, but it is unknown which devices were explanted and the prosthesis later implanted in exchange.A subsequent revision surgery was reported to occur on (b)(6)2017, although its perioperative diagnostic, implants involved, and general outcome is unknown.

Manufacturer Narrative

It was reported that a revision surgery was performed on the patient's right hip.As of today, the implanted devices all of which were used in the treatment, and additional information has been requested for this complaint but has not become available.Without definitive lot numbers, a complete complaint history review cannot be performed for the devices involved.As no device batch numbers were provided for investigation, a manufacturing record review and device labelling / ifu review could not be performed.All of the devices would have met manufacturing specifications at the time of production.If more information is received, this investigation will be reopened.A risk management review was performed.No additional risks were identified as a result of the reported event and no further actions are required at this time.The available medical information has been reviewed.Based on the reported symptoms it cannot be concluded that the events/clinical reactions (metallosis, elevated serum chromium and cobalt levels, pain, loss of balance, dizziness, ambulatory difficulties, tissue dehiscence and necrosis, bone necrosis, hypertrophic scarring and lumbar strains) were associated with a mal-performance of the implant.The patient impact cannot be determined at this time.Without 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 the results of this investigation, the need for corrective or preventative action is not indicated.

Event Description

It was reported that, after a primary bhr-tha construct had been implanted on the plaintiff¿s right hip on (b)(6) 2007, the plaintiff experienced metallosis, elevated serum chromium and cobalt levels, pain, loss of balance, dizziness, ambulatory difficulties, tissue dehiscence and necrosis, bone necrosis, hypertrophic scarring and lumbar strain.Additional surgeries were performed on (b)(6) 2017 and on (b)(6) 2017 to address this event by replacing the products.There was noticed an increased subsidence of the femoral stem when compared with previous, which raised suspicion for component loosening.Patient's current health status is unknown.

Manufacturer Narrative

Additional information added: a3, d4 (udi number), d6b, d10.Corrected data: b5, d1, d4 (catalog number), h6(health effect - clinical code).

Manufacturer Narrative

It was reported that a revision surgery was performed due to metallosis, elevated serum chromium and cobalt levels, pain, loss of balance, dizziness, ambulatory difficulties, tissue dehiscence and necrosis, bone necrosis, hypertrophic scarring and lumbar strain.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.A review of the historical complaints data for the devices concerned was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the modular head.Similar complaints have been identified for the modular head and sleeve.However, as the devices are no longer sold, no action is to be taken.In the absence of the actual device, the production records were reviewed for the modular sleeve reportedly involved in this incident.All released sleeves involved met manufacturing specifications upon release for distribution.As no modular head batch number was provided for investigation, manufacturing record review could not be performed for the device.If more information is received, this investigation will be reopened.The review of the products 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.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.The available medical documents were reviewed.Based on the reported symptoms it cannot be concluded that the events/clinical reactions (metallosis, elevated serum chromium and cobalt levels, pain, loss of balance, dizziness, ambulatory difficulties, tissue dehiscence and necrosis, bone necrosis, hypertrophic scarring and lumbar strains) were associated with a mal-performance of the implant.The patient impact cannot be determined at this time.Based on the available information we can confirm the reported complaint, however without further information our investigation remains inconclusive, and a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.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: BHR MODULAR HEAD 50MM
• 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; austin, TX 78735 ; 5123913905
• MDR Report Key: 12532566
• MDR Text Key: 273326089
• Report Number: 3005975929-2021-00435
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010578716
• UDI-Public: 3596010578716
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 74222150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2023
• 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
• Treatment: PN: 71341024 / LOT: 07BM01656; PN: 74222200 / LOT: 10059
• Patient Outcome(s): Required Intervention
• Patient Sex: Male