MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR RESURFACING FEMORAL HEAD 42MM; PROSTHESIS, HIP, FEMORAL, RESURFACING

Catalog Number 74121142

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Pain (1994); No Information (3190)

Event Date 08/29/2011

Event Type  Injury  

Event Description

It was reported that patient underwent left hip revision surgery due to femoral neck fracture.

Manufacturer Narrative

[(b)(4)].

Manufacturer Narrative

It was reported that left 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.Patient twisted on the hip and felt a pop in her hip and had immediate pain and inability to move her left hip.There were findings on x-ray of noted dislodgement of the femoral component.Intraoperatively, there was a significant fracture hematoma located, which was evacuated.This was about 100 ml of blood.The patients twisting movement cannot be ruled out as a contributing factor to her pain and clinical status.The hematoma found intraoperatively cannot be ruled out as a contributing factor to the pain and inability to move.Without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, 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, and our investigation remains inconclusive.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 42MM
• 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: 7095438
• MDR Text Key: 94104753
• Report Number: 3005975929-2017-00448
• Device Sequence Number: 1
• Product Code: KXA
• 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
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Catalogue Number: 74121142
• Device Lot Number: 085299
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETABULAR CUP, # 74120150, LOT # 090204; ACETABULAR CUP, PART AND LOT # UNKNOWN; ACETABULAR CUP, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR