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

Catalog Number 74121150

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Injury (2348)

Event Date 11/21/2017

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to femoral neck fracture.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to a fractured stem and femoral neck fracture.During the revision the bhr head and bhr cup were removed.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.According to the provided revision report, the patient started having increasing pain about 2 months before the revision.The femoral neck fracture was diagnosed.Based on the review of the provided surgical report, it remains unclear whether the peg of the femoral component fractured as well.No possible explanation was provided.Review of the provided implantation and revision report did not reveal any inconsistencies related to the surgical technique that could explain the revision or indicated any findings that could have contributed to the reported neck fracture.Without x-rays or the device available it also remains unclear whether the peg of the femoral component fractured as well.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: RESURFACING FEMORAL 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 CV31 3HL; UK CV31 3HL
• MDR Report Key: 7612853
• MDR Text Key: 111430550
• Report Number: 3005975929-2018-00208
• Device Sequence Number: 1
• Product Code: NXT
• 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
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: 74121150
• Device Lot Number: 10HW29533
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 06/05/2018
• Supplement Dates FDA Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETLR CUP HAP 56MM 74120156 LOT 10EW27755; FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR