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

Model Number 74121150

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Joint Dislocation (2374); Ambulation Difficulties (2544); Implant Pain (4561)

Event Type  Injury  

Event Description

It was reported that the plaintiff underwent a primary right hip bhr surgery on (b)(6)2015.On an unspecified date, the plaintiff started experiencing right hip problems: a lot of pain, a clicking sound, he can barely walk, and if he bumps into something the hip will pop out.The plaintiff has had physical therapy and multiple tests performed but has not found any relief.No more information has been reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

Additional information: d1, d4, d10, h4.

Manufacturer Narrative

It was reported that after a primary right hip bhr surgery, the plaintiff experienced a lot of pain, a clicking sound, he can barely walk, and if he bumps into something the hip will pop out.As of today, the devices, all of which were used in treatment, remain implanted and therefore cannot be tested.A review of the historical complaints data for the devices concerned was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the cup and the head, 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 requested clinical documentation has not been provided for evaluation.Therefore, there were no clinical factors found which would have contributed to the reported clinical symptoms.The patient has not been revised as of this date.The impact to the patient beyond that which already has been reported could not 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 muscle and fibrous tissue laxity and malpositioning of the implants leading to postoperative joint instability.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: 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 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: 16823826
• MDR Text Key: 314097046
• Report Number: 3005975929-2023-00057
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502797
• UDI-Public: 03596010502797
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2019
• Device Model Number: 74121150
• Device Catalogue Number: 74121150
• Device Lot Number: 14HW21190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2014
• 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
• Treatment: 74120156/14HW03868/ACETLR CUP HAP 56MM W/ IMPTR.; UNKNOWN BIRMINGHAM HIP RESURFACING (BHR) CUP.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male