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
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/04/2018
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1020279-2018-02955
• Device Sequence Number: 2069303
• Product Code: MEH
• UDI-Device Identifier: 03596010561336
• UDI-Public: 03596010561336
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K052426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 12/31/2018
• Supplement Report FDA Received Date: 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4); (B)(4)
• Outcome Attributed to Adverse Event: Other; Required Intervention