MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMF STEM WITH STIKTITE SZ 2; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLY

Catalog Number 71352502

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 10/12/2018

Event Type  Injury  

Event Description

It was reported that the patient was implanted with an r3 system in her left hip on (b)(6) 2012.She was subsequently diagnosed with metallosis and, as a result, underwent revision surgery on (b)(6) 2018.

Manufacturer Narrative

The devices, used in treatment were not returned for evaluation, reporting event could not be confirmed.A clinical evaluation was conducted and confirms it was reported that the patient was implanted with an r3 system in her left hip on september 13, 2012.She was subsequently diagnosed with metallosis and, as a result, underwent revision surgery on october 12, 2018.The implantation operative report was reviewed, but does not offer information that will aid in the investigation.The provided lab report of cobalt 18.6 ¿g/l is noted to be elevated, but without additional medical information the root cause cannot be determined.Without supporting medical documentation, a thorough medical assessment of the reported metallosis and subsequent revision cannot be performed.In the event medical/clinical records are received, the clinical task will be re-opened and a thorough assessment will be rendered at that time.Some potential probable causes for this event could include damaged product, implant corrosion or wear.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

Event Description

It was reported that the patient was implanted with an r3 system in her left hip on (b)(6) 2012.She was subsequently diagnosed with metallosis due to a dual taper femoral stem and, as a result, underwent revision surgery on (b)(6) 2018.The stem and the femoral head were explanted and replaced with competitor¿s devices.The patient tolerated the procedure well.

• Brand Name: SMF STEM WITH STIKTITE SZ 2
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038
• MDR Report Key: 9729679
• MDR Text Key: 180787922
• Report Number: 1020279-2020-00640
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71352502
• Device Lot Number: 12HM12966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2022
• 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; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female