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

Model Number 74121146

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Bone Fracture(s) (1870); Pain (1994); Arthralgia (2355)

Event Date 02/22/2016

Event Type  Injury  

Manufacturer Narrative

Complaint reference: (b)(4).

Event Description

It was reported that the patient suffered a skiing accident on (b)(6) 2016, due to the accident the patient suffered a right acetabular fracture and pain.No medical intervention was performed to treat the adverse event.

Manufacturer Narrative

It was reported that the patient suffered a skiing accident, due to the accident the patient suffered a right acetabular fracture and pain.The patient was hospitalized but no fracture was confirmed.The implanted devices were used in treatment.Additional information has been requested for this complaint but has not become available.As no device batch numbers were provided for investigation, a manufacturing record and complaint history could not be performed.If more information is received, this investigation will be reopened.As the precise part number and batch number for the reported devices involved were not provided, a review of the ifus for bhr cups and bhr heads from initial release in usa up to the implantation date of the devices were reviewed.Adequate warnings and precautions in relation to the alleged failure modes were found.A risk management review was performed.No additional risks were identified as result of the reported event.The available medical documents were reviewed.The medical imaging reports do not note findings consistent with the complaint description of a right acetabular fracture.The reported pain is a result of the skiing accident and is not associated with a malperformance of the implant.Based on the information provided a probable root cause for the reported pain is the patient¿s skiing accident.Furthermore, the ifus reviewed state, ¿excessive physical activity levels, excessive patient weight, and trauma to the joint replacement may cause early failure of the implant¿.If additional information becomes available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

Event Description

It was reported that the patient suffered a skiing accident on (b)(6) 2016.Due to the accident the patient suffered a right acetabular fracture and pain.The patient was hospitalized, but no surgical intervention was performed to address the issue.This patient had a right hip bhr primary surgery on (b)(6) 2019.

Manufacturer Narrative

H4: manufactured date.

Manufacturer Narrative

H3, h6: it was reported that the patient suffered a skiing accident on (b)(6) 2016.Due to the accident the patient suffered a suspected right acetabular fracture and pain.The patient was hospitalized, but no surgical intervention was performed to address the issue since fracture was not confirmed.The implanted devices were used in treatment.A review of the historical complaints data for the acetabular cup and the femoral head 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.Other complaints were identified to involve this batches.No other similar complaints were identified for the part number and the reported/related failure mode for the acetabular cup.Other similar complaints were identified for the part number and the reported/related failure mode for the femoral head.However, as the 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 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.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 required.The available medical documents were reviewed.The medical imaging reports do not note findings consistent with the complaint description of a right acetabular fracture.The reported pain is a result of the skiing accident and is not associated with a malperformance of the implant.Based on the information provided we cannot confirm or further investigate the reported complaint.A probable root cause of the reported pain is the skiing accident and is not associated with a malperformance of the implant.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: RESURFACING FEMORAL 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: 10958167
• MDR Text Key: 219864822
• Report Number: 3005975929-2020-00482
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502780
• UDI-Public: 03596010502780
• 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,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Model Number: 74121146
• Device Catalogue Number: 74121146
• Device Lot Number: 086522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2008
• 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): Disability
• Patient Age: 54 YR
• Patient Sex: Female