MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RF I POR HA ACET SHELL 58MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71330158

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 05/25/2018

Event Type  Injury  

Event Description

It was reported that patient had bilateral hip replacements done on (b)(6) 1999 , then on (b)(6) 2017 patient presented pain in both hips, so it was decided that a revision of the acetabular component would be done.Patient underwent a removal of a reflection cup and ceramic head.

Manufacturer Narrative

Contains new information.The head, shell and acetabular liner were returned and evaluated.The listed fix peg was not returned.A lab analysis noted that this specific shell does not have a feature to accept a peg so clearly not a part of this complaint.The shell and liner were received in the assemble state.Visual observation of the backside of the shell revealed on-growth covering roughly 40% of the hemi spherical surface and no damage was found on the visually available surface.Some gouges and scoring were noted on the available surface of the liner, which were most likely the result of instrument contact during removal.A crack across the superior flange was also visible.With the head placed in the id of the liner, visible wear of the poly id superior edge is exhibited.A slight yellowing of the poly liner has occurred.This is common for poly components which have been implanted for a period of time.The head did not display any physical changes with the exception of one transfer mark on the articular surface.Most likely made contact with an instrument during removal.A threaded hole cover was utilized with the shell.It remained fixed within the shell with no notable observations.A clinical evaluation noted that a tha revision after approximately 19 years is not an unexpected event; however, the reported pain was likely a contributing factor to the revision tha.Additionally, the time elapsed between the reported onset of hip pain and revision could have also been a contributing factor.Without the ct report the root cause cannot be concluded.The patient impact beyond the reported symptoms and hip revision cannot be determined.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: RF I POR HA ACET SHELL 58MM
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• 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
• MDR Report Key: 7611202
• MDR Text Key: 111389076
• Report Number: 1020279-2018-01152
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71330158
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2018
• 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): Other; Required Intervention