MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMP 13 STEM PRIMARY SO; PROSTHESIS, HIP, SEMI-CONST, UNCEM, METAL/POLYM, NON-POR, CALICUM-PHOSPHATE

Catalog Number	71291301
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Dr revised an emperion stem that had been implanted approximately 9 years ago; the stem had fractured inside the top of the cone.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.The lab analysis concluded, the stem was fractured in the proximal sleeve taper region.Radial lines were observed on the fracture surface.Signs of fretting on the lateral side of the proximal taper region of the stem were observed.The crack initiated most likely in the lateral region of the stem.Bone "ingrowth" was observed on the porous coated regions of the sleeve.Scratching and damage was observed on the porous coated regions of the sleeve and the distal region of the stem that likely occurred during removal of components.The analysis showed that the emperion stem fractured likely occurred in the lateral region of the stem.Fatigue was most likely the fracture mechanism.No defects in material or manufacturing were found during the course of this evaluation.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.The clinical/medical team concluded, based on the results of the product analysis fatigue was most likely the fracture mechanism.However, the length of time in-situ, as well as the patient¿s weight of 148kg/325.6lbs,and lack of bone support around the proximal stem, cannot be ruled out as contributing factors.The future impact to the patient beyond the revision cannot be concluded.No further clinical/medical assessment is warranted at this time.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: EMP 13 STEM PRIMARY SO
• Common Device Name: PROSTHESIS, HIP, SEMI-CONST, UNCEM, METAL/POLYM, NON-POR, CALICUM-PHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7564010
• Report Number: 1020279-2018-01033
• Device Sequence Number: 11281136
• Product Code: MEH
• UDI-Device Identifier: 03596010561480
• UDI-Public: 03596010561480
• Combination Product (Y/N): N
• PMA/510(K) Number: K042127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2019

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: No Information
• Device Catalogue Number: 71291301
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2018
• Supplement Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 06/02/2018
• Supplement Report FDA Received Date: 01/25/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 148