MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP HAP SIZE 52/58; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74122158

Device Problems Collapse (1099); Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Necrosis (1971); Pain (1994); Injury (2348); Hip Fracture (2349); Implant Pain (4561)

Event Date 12/09/2016

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on the patients left hip due to pain, mechanical loosening of the bhr device: femoral neck collapse with displacement of the femoral head in relation to the femoral neck.The patient outcome is unknown.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review and device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.Smith and nephew has not received device/adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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.

Manufacturer Narrative

It was reported that, after undergoing left hip bhr resurfacing surgery due to osteoarthritis and hip dysplasia, the patient experienced pain, aseptic necrosis, femoral neck fracture, along with a loose femoral component.These events were treated by performing a revision surgery, in which both the acetabular and femoral component were explanted and replaced with a competitor's tha system.Patient's current health status is unknown.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.A review of the historical complaints data for the devices concerned was performed using batch number, part number and the reported failure mode to evaluate patterns of repeated failures or defects.No similar complaints have been identified for the cup, and this failure will continue to be monitored.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.The 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, no prior applicable escalation actions were identified.The available medical documents were reviewed.It is unknown to what extent the patient¿s workout using a recumbent bike had on the reported events.However, based on the information provided, the clinical root cause of the reported aseptic necrosis, loosening, and femoral neck fracture cannot be confirmed.It cannot be concluded that the reported clinical symptoms were associated with a malperformance of the implant.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.A definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement.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.

Event Description

It was reported that, after undergoing left hip bhr resurfacing surgery on (b)(6) 2009 due to osteoarthritis and hip dysplasia, the patient experienced pain, aseptic necrosis, femoral neck fracture, along with a loose femoral component.These events were treated by performing a revision surgery on (b)(6) 2016, in which both the acetabular and femoral component were explanted and replaced with a competitor's tha system (depuy orthopaedics).Patient's current health status is unknown.

• Brand Name: BHR ACETABULAR CUP HAP SIZE 52/58
• 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: 10656323
• MDR Text Key: 211659835
• Report Number: 3005975929-2020-00373
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552310
• UDI-Public: 03596010552310
• 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
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2013
• Device Model Number: 74122158
• Device Catalogue Number: 74122158
• Device Lot Number: 08JW18794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2008
• 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): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male