MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN R3 SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number UNKNOWN

Device Problem Biocompatibility (2886)

Patient Problems Burning Sensation (2146); Metal Related Pathology (4530); Implant Pain (4561)

Event Date 04/08/2022

Event Type  Injury  

Event Description

It was reported that, after undergoing r3-tha surgery on (b)(6) 2018, the patient experienced pain and a squeaking noise in the surgical area.Steroid shots were prescribed to ease the pain.This symptom persisted for two years, along with burning and sensitivity in her leg and hip, for which opioids were recommended.On (b)(6) 2022, the patient consulted these symptoms with a different surgeon, who indicated she had metal shavings and shattering in her leg.On (b)(6) 2022, a revision surgery was conducted in order to replace the socket.Patient's current health status is unknown.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

H3.H6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that there were no clinical factors found which would have contributed to the reported event/clinical reactions.The patient impact beyond the reported revision cannot be determined with the limited information provided.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 review 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.Factors that could contribute to the reported event include alignment, abnormal motion over time and/or irregular implant interaction.Based on this investigation, the need for corrective action is not indicated.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.

• Brand Name: UNKNOWN R3 SHELL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• 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: 16887786
• MDR Text Key: 314756312
• Report Number: 1020279-2023-01002
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2023
• 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 Sex: Female