MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMP STEM 9 SO 140MM; PRSTHSIS,HIP,SMI-CNSTRAIND,UNCMNTD,METAL/POLYMR,NON-POROUS, CALICUM-PHOSPHATE

Catalog Number	71290902
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 associated complaint device was not returned.The clinical/medical team concluded, the 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.In addition, the product evaluation confirmed the stem breakage was due to fatigue.However, without the revision report, or the post implantation radiographs we cannot rule out misalignment as a possible contributing factor.The impact to the patient beyond the revision cannot be determined.Should additional information become available this issue can be re elevated.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re opened.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Reviewed during mimb.A medical investigation will be performed.Proceed based on information provided/available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by (b)(6), medical director.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: patient information.Surgical procedure/post-operative care review.Device labeling (including technique guides, ifus, etc.).

• Brand Name: EMP STEM 9 SO 140MM
• 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: 8206177
• Report Number: 1020279-2018-02952
• Device Sequence Number: 19323036
• Product Code: MEH
• UDI-Device Identifier: 03596010561275
• UDI-Public: 03596010561275
• 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): 06/09/2019

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: 71290902
• Device Lot Number: 06GM13128
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 12/31/2018
• Supplement Report FDA Received Date: 06/09/2019
• 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: 71343204/09BM02196; 71343204/09BM02196
• Outcome Attributed to Adverse Event: Other; Required Intervention