MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN R3 SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number UNKN01100901

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

Patient Problems Inflammation (1932); Joint Laxity (4526)

Event Date 03/15/2018

Event Type  Injury  

Event Description

It was reported that, after a total hip replacement construct had been implanted on the patient¿s left hip on (b)(6) 2013, the patient experienced persistent pain, iliopsoas tendinitis, groin pain with hyperflexion and increased acetabular anteversion as stated by the surgeon upon conducting postoperative x-rays on (b)(6) 2019.The patient underwent ultrasound guided therapeutic injections of the left iliopsoas tendon with steroids and anesthetics since (b)(6) 2018 with temporary symptom relief, but despite these actions the pain was negatively impacting his quality of life and limiting normal daily activities.No additional follow up reports were provided to review the clinical course of the patient related to the left hip prosthesis (b)(4).

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the reported persistent pain, and groin pain with hyperflexion are likely related to the reported iliopsoas bursitis and/or increased acetabular anteversion.It cannot be concluded that the reported events/clinical reactions were associated with a mal performance of the implant or implant failure.The patient impact beyond the reported events and conservative treatment cannot be determined with the provided information.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include patient condition.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

Manufacturer Narrative

H3, h6: the reported event was analyzed.Although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the acetabular component.Therefore, no investigation is deemed for the other devices.Given the nature of the alleged incident, the device, could not be returned for evaluation; therefore, a device analysis could not be performed.However, based on the information provided, the unsatisfactory experience could be confirmed.The clinical/medical investigation concluded that, patient had bilateral hip replacements in 2013.No revision has been reported for his left hip.A physicians¿ note indicates, patient complained of left hip pain in 2017.Underwent injection left groin iliopsoas tendon with temporary relief.Ultrasound and magnetic resonance imaging of left hip indicated increased acetabular anteversion, iliopsoas bursitis, mild stress reaction, old arthritic change, and a small joint effusion.It is noted conservative treatment options including weight loss, injections, pain medication, and low impact exercises were advised.The reported persistent pain, and groin pain with hyperflexion are likely related to the reported iliopsoas bursitis and/or increased acetabular anteversion.It cannot be concluded that the reported events/clinical reactions were associated with a mal performance of the implant or implant failure.The patient impact beyond the reported events and conservative treatment cannot be determined with the provided information.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, instructions for use, risk management file and prior actions could not be performed.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKN R3 SHELL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• 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: 15415287
• MDR Text Key: 299830411
• Report Number: 1020279-2022-04087
• Device Sequence Number: 1
• Product Code: NXT
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01100901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Male
• Patient Weight: 111 KG