MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMPERION SLEEVE; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

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

Patient Problem Pain (1994)

Event Date 02/22/2018

Event Type  Injury  

Event Description

It was reported that a patient booked for a hip revision due to thigh pain.Surgeon planned to remove all component and re insert prosthesis.Further confirmation of devices removed should be provided soon.

Manufacturer Narrative

The associated complaint devices were returned to be evaluated.A review of complaint history revealed no prior complaints for the listed lots.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.Visual inspection of the assembled sleeve and femoral component revealed marks and gouges exhibited on proximal region of stem, along sides of sleeve and on distal stem.Biological material appearing to be bone was observed attached on anterior, posterior and medical side of sleeve.No irregularities were observed regarding the femoral taper.Sleeve appeared to be well locked to stem component.The shell shows material which appeared to be bone was observed to be covering an estimated 50% area of shell od.The id of the shell appeared to be normal.Visual inspection of liner shows the backside of liner exhibited yellow staining.A portion of the rim was broken.The id did not exhibited signs of wear.A screw used to remove the liner from the shell was left in place.The retrieved components do not provide evidence leading to any conclusion regarding the issues reported.Our clinical/medical team concluded that no clinical information was provided for inclusion in this investigation.One (1) x-ray photo was provided that doesn't show a clear cause of the reported pain.The visual inspection concluded the retrieved components did not provide evidence leading to any conclusion regarding the reported thigh pain.Based on the visual inspection the root cause of the thigh pain cannot be concluded.The future impact to the patient beyond the revision cannot be determined.No further clinical/medical assessment is warranted at this time.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this investigation closed.Credit cannot be issued for these devices.

• Brand Name: EMPERION SLEEVE
• 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: markus poettker ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7353470
• MDR Text Key: 102921388
• Report Number: 1020279-2018-00352
• 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: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention