MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR RESURFACING FEMORAL HEAD 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74123152

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Inadequate Osseointegration (2646); Unequal Limb Length (4534); Insufficient Information (4580)

Event Date 11/08/2022

Event Type  Injury  

Manufacturer Narrative

Complaint reference number: (b)(6).

Event Description

It was reported that, after a bhr system had been implanted on an unspecified date, the plaintiff experienced an unspecified adverse event that was addressed via revision surgery on 08-nov-2022.No additional information was provided.

Manufacturer Narrative

H3, h6: it was reported that a revision surgery was performed due to an unspecified adverse event.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, or definite escalation actions review could not be performed.A review of the product¿s instructions for use was not possible due to limited information about the details of the event and device.Without basic part details or an alleged failure mode, no risk file review is possible.No further actions are required at this time.If more information is received, this investigation will be reopened.The requested supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the unspecified complications.With the limited information provided, the patient impact beyond the reported revision cannot be determined.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.A definitive root cause cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.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.

Manufacturer Narrative

H3, h6.It was reported that a right hip revision surgery was performed due to failed bhr system without further information and the femoral head was loose.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.No other similar complaints have been identified for the cup and the head.However, this failure will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.The review of the product 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, no prior applicable escalation actions were identified.The available medical documents were reviewed.The one-centimeter leg length discrepancy may be consistent with the reported loose femoral component.However, with the limited information provided the clinical root cause of the loose femoral component, and 1cm leg length discrepancy cannot be definitively concluded.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.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.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.H11.Corrected information in h6 (health effect - clinical code and medical device problem code).

Manufacturer Narrative

A1, a2, a3, b5, d1, d2a, d2b, d4, d10, g4.

Event Description

It was reported that, after a right bhr procedure was performed on the (b)(6) 2012, the patient was presented with a failed bhr system without further information.The patient underwent a revision surgery on the (b)(6) 2022.During the procedure it was found that the right leg was shorter by 1 cm.The patient received a tha system in exchange, the acetabular component was maintained.The patient was then taken to the recovery room.

Event Description

It was reported that, after a right bhr procedure was performed on (b)(6) 2012, the patient was presented with a failed bhr system and suffered symptomatic metal on metal hip implant system and elevated cobalt and chromium ion levels.The patient underwent a revision surgery on the (b)(6) 2022.During the procedure it was found that the right leg was shorter by 1 cm and the femoral head was loose.The patient received a tha system in exchange, the acetabular component was maintained.The patient was then taken to the recovery room.

Manufacturer Narrative

Additional information: b5, d6a, h6 (health effect - clinical code and medical device problem code).

• Brand Name: BHR RESURFACING FEMORAL HEAD 52MM
• 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: 16936524
• MDR Text Key: 315263643
• Report Number: 3005975929-2023-00082
• Device Sequence Number: 1
• Product Code: NXT
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2017
• Device Model Number: 74123152
• Device Catalogue Number: 74123152
• Device Lot Number: 12AW35806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 74122158 / LOT: 12BW36005.
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male