MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR RESURFACING FEMORAL HEAD 54MM; PROSTHESIS, HIP, FEMORAL, RESURFACING

Catalog Number 74121154

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Injury (2348); Hip Fracture (2349); No Code Available (3191)

Event Date 05/03/2010

Event Type  Injury  

Event Description

It was reported that right hip revision surgery of the femoral component only was performed due to femoral neck fracture.Subsequent revision of same hip side thr components reported via mdr 3005975929-2017-00351.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to femoral neck fracture.During the revision only the bhr head was revised.As of today, device return and additional information has been requested for this complaint but has not become available.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.The available medical documents were reviewed.Review of the provided implantation report did not reveal any inconsistencies related to the surgical technique that could explain the later revision.According to the provided revision report, the patient has been very active after the implantation and the surgeon had the suspicion that the activity lead to a stress fracture.Based on the provided documents, presumably, the excessive physical activity led to the fracture.Notching of the femoral neck or varus position of the femoral components can also lead to a neck fracture.However, there is no indication that notching or varus positioning occurred.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, however the available information suggests the potential root cause of improper loading due to the activity levels of the patient.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the bhr head was removed.The bhr cup remained implanted.As of today, device return and additional information has been requested for this complaint but has not become available.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.The available medical documents were reviewed.The patient had a right resurfacing conversion to a tha 6 weeks post implantation.X-rays showed a comminuted right femoral neck fracture.A physician¿s office note indicated that the patient had a successful hip resurfacing, but then got a stress fracture, possibly from being very active, very early.It cannot be determined to what extent the patient¿s early strenuous activity and the physical demands of his working on his farm had on his clinical status.With the information provided, the root cause of the reported fracture cannot be confirmed, and it cannot be concluded that the reported event was associated with a mal-performance of the implant.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.However, based on the available information, a root cause of an adverse incident has been selected due to the early activity post-implantation.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: BHR RESURFACING FEMORAL HEAD 54MM
• Type of Device: PROSTHESIS, HIP, FEMORAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 6968176
• MDR Text Key: 89932509
• Report Number: 3005975929-2017-00380
• Device Sequence Number: 1
• Product Code: KXA
• UDI-Device Identifier: 03596010502803
• UDI-Public: 03596010502803
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Catalogue Number: 74121154
• Device Lot Number: 089396
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2017
• Patient Sequence Number: 1
• Treatment: ACETABULAR CUP, # 74120160, LOT # 090001
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR