MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMP 13 STEM PRIMARY HO; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number	71291302
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	12/04/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a fracture of emperion femoral stem.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, right hip (b)(4).The intra-operative findings confirmed the fracture of the modular femoral component at the stem-sleeve modular junction.However, without the requested explants or pre and post implantation radiographs, the root cause of the right hip femoral stem fracture cannot determined; however, we cannot rule out the patient¿s hiv disease progression, applications of loads in excess of the material¿s strength, and/or poor bone quality, body habitus (weighing 298 lbs), anti-retroviral and corticosteroid use, high cholesterol, cigarette and alcohol use, and bilateral knee surgeries as likely contributing factors to the implant failure and not the fault of the smith and nephew device itself.The patient impact beyond the right hip revision cannot be determined.Left hip (b)(4).Based on the intra-operative findings the reported infection was consistent with staphylococcus epidemidis with bio-film noted in the retro-acetabular.However, the root cause of the reported infection cannot be determined.In addition, we cannot rule out the patient¿s hiv disease progression, bone quality, body habitus, anti-retro viral and corticosteroid use, diabetes, cigarette and alcohol use cannot be ruled out as likely contributing factors to the reported infection and not the fault of the smith and nephew device.The patient impact beyond the right hip revision cannot be determined.No further clinical/medical assessment is warranted at this time.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 parts revealed no prior complaints for the listed batches.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.

• Brand Name: EMP 13 STEM PRIMARY HO
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8024781
• Report Number: 1020279-2018-02316
• Device Sequence Number: 11133917
• Product Code: MEH
• UDI-Device Identifier: 03596010561497
• UDI-Public: 03596010561497
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K042127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2019

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 Expiration Date: 10/27/2018
• Device Catalogue Number: 71291302
• Device Lot Number: 08KM22189
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 10/08/2018; 10/08/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 11/06/2018; 06/05/2019
• 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: 71291665/08LAB0004; 71335554/08EM03006; 71335556/09AM23773; 71336525/08BT17349; 71341156/08MW20567; 74122544/08CW16093; 74222200/08CW16025
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 135