MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN R3 LINER CERAMIC POLY; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number UNKNOWN

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Metal Related Pathology (4530)

Event Date 04/09/2019

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

Us legal mdl.It was reported that, after a primary r3-tha construct had been implanted on the plaintiff¿s right hip on (b)(6) 2012, the plaintiff experienced severe pain, stiffness, loss of mobility, trunnionosis and metal reaction.A revision surgery was performed on (b)(6) 2019 to treat this adverse event; the chromium/cobalt femoral head and r3 polyethylene liner were explanted.The plaintiff¿s outcome is unknown.

Manufacturer Narrative

H3, h6: it was reported that right hip revision surgery was performed.During the revision, the modular head and r3 liner were explanted.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.Since part/lot details were not received for investigation no thorough manufacturing record review or assessment of the reported event can be performed.If the products or additional information become available in the future, the tasks will be reopened and performed.However, the released devices would have met manufacturing specifications at the time of production.A risk management review was performed.No additional risks were identified as result of the reported event.No further actions are required at this time.The available medical documents were reviewed and based on the reported symptoms it cannot be concluded that the events/clinical reactions (severe pain, stiffness, loss of mobility, trunnionosis, metal reaction) were associated with a mal performance of the implant.The patient impact cannot be determined at this time.Without the return of the actual products involved or additional information, our investigation remains inconclusive, and a definitive root cause cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.Should the device 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 R3 LINER CERAMIC POLY
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12701268
• MDR Text Key: 278543847
• Report Number: 1020279-2021-07680
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2021
• Was Device Evaluated by Manufacturer?: No
• 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; Other