MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKN BIRMINGHAM HIP RESURFACING (BHR) HEAD; PROSTHESIS,,HIP,HEMI-,TRUNNIONBEARING,FEMORAL,METALPOLYACETAL

Catalog Number UNKNOWN

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

Patient Problem Hip Fracture (2349)

Event Date 04/07/2022

Event Type  Injury  

Event Description

It was reported that after a thr performed on an unknown date the patient experienced a femur neck fracture of traumatic nature.This was addressed via revision surgery on (b)(6) 2022 and the bhr femoral component was explanted.The patient current status is unknown.

Manufacturer Narrative

H3, h6: it was reported that after a thr performed on an unknown date the patient experienced a femur neck fracture of traumatic nature.This was addressed via revision surgery on (b)(6) 2022 and the bhr femoral component was explanted.The patient current status is unknown and the device, used in treatment, was not returned for analysis.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.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 are required.A risk management review was performed for the femoral head.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.Smith and nephew has not received the device/ adequate materials to fully evaluate the complaint from a clinical perspective, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Based on the information received, the likely root cause of the event is the patient's femoral neck fracture, however further details are required in order to establish potential factors leading to this event.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: UNKN BIRMINGHAM HIP RESURFACING (BHR) HEAD
• Type of Device: PROSTHESIS,,HIP,HEMI-,TRUNNIONBEARING,FEMORAL,METALPOLYACETAL
• 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 ; austin, TX 78735 ; 5123913905
• MDR Report Key: 14283224
• MDR Text Key: 290800837
• Report Number: 3005975929-2022-00186
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male