MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMP SLV 9 MD CONE 3 SPOUT SLOT; PRSTHSIS,HIP,SMI-CNSTRAIND,UNCMNTD,METAL/POLYMR,NON-POROUS, CALICUM-PHOSPHATE

Catalog Number 71290923

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 12/04/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to periprosthetic fracture/implant failure.Due to where the fracture of the prosthesis was, couldn't use emperion removal instruments and removal of stem was difficult as the distal stem was well fixed.Then cut base of sleeve however was unable to remove it.Then tried the trephines over the stem and still unable to free the stem.So an extended trochanteric osteotomy was performed, strut graft and the longest accord trochanteric grip plate was used over the restoration hip system with 9 cables in total.The liner was not replaced.

Manufacturer Narrative

The affected emperion stem, emperion porous plus sleeve and oxinium femoral head were returned and evaluated.A lab analysis conducted during this investigation indicated that scratches seen on the femoral neck were likely caused by removal.The fatigue fracture began with a crack on the lateral side of the stem that propagated.Fatigue striations can be seen on the fracture surface.The sleeve had bone ingrowth indicating good proximal fixation; gouging and damage on the sleeve was likely caused during removal.The stem was sectioned underneath the sleeve as reported in the complaint.The cross-sectioned surface is observed on the section of the stem inside the sleeve and on the distal section of the femoral stem.A lot of bone ingrowth was seen on the stem which indicates good distal fixation.A clinical evaluation noted that x-rays provided confirm the broken stem and possible stress shielding around the greater trochanter which would indicate lack of support of the neck of the stem.However, without the revision report, or the post implantation radiographs a misalignment as a possible contributing factor cannot be ruled out.The impact to the patient beyond the revision cannot be determined.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: EMP SLV 9 MD CONE 3 SPOUT SLOT
• Type of Device: PRSTHSIS,HIP,SMI-CNSTRAIND,UNCMNTD,METAL/POLYMR,NON-POROUS, CALICUM-PHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8206859
• MDR Text Key: 131733763
• Report Number: 1020279-2018-02955
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03596010561336
• UDI-Public: 03596010561336
• Combination Product (y/n): N
• PMA/PMN Number: K052426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71290923
• Device Lot Number: 06BAB0001E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/31/2018
• Supplement Dates Manufacturer Received: 12/04/2018
• Supplement Dates FDA Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (B)(4); (B)(4)
• Patient Outcome(s): Other; Required Intervention