MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMP 13 STEM PRIMARY HO; PRSTHSIS,HIP,SMI-CNSTRND,UNCMNTD,MTAL/PLYMR,NON-PORS,CALICUM-PHSPHTE

Catalog Number	71291302
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Reaction, Injection Site (2442)
Date of Event	07/20/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2011 a medical intervention was performed due to pain.A steroid injection was performed to treat severe pain the patient was presenting.
Additional Manufacturer Narrative
The associated complaint devices was returned and evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A lab analysis indicated that the sleeve exhibits bone on/ingrowth on the medial side; the amount suggests the cone was well fixed prior to removal.The sleeve was well fixed is the missing porous coating on the proximal lateral area of the sleeve as this was likely the result of instrument contact.A potential fracture initiation site is visible at the lateral mating edge of the sleeve and stem component.A piece of the stem below the lower calcar platform was returned.An sem examination of the fracture surface of this piece supports the earlier observation of the potential crack initiation site being at the lateral mating surface of the sleeve and stem.Edxs analysis within the fracture site did not find any foreign or unexpected constituents in the material.The fracture surface reveals characteristics consistent with a fatigue fracture.A clinical analysis indicated that based on the available information, the root cause of the first revision was the broken stem that resulted from the stated fall.The clinical symptoms of the reported of "hip pain" and osteolysis of the greater trochanter may be consistent with an adverse reaction to metal debris but this cannot be confirmed based on the information provided as well this could also be lack of support around the proximal stem due to stress shielding.The root cause for the second revision due to "loosening" just 8 months later cannot be concluded.However, it is unknown if the use of third party components added to the issue of "loosening".No current information or patient history has been provided for this assessment.Should information become available this complaint can be re-assessed.Based on this investigation, the need for corrective action is not indicated.We consider this investigation closed.

• Brand Name: EMP 13 STEM PRIMARY HO
• Common Device Name: PRSTHSIS,HIP,SMI-CNSTRND,UNCMNTD,MTAL/PLYMR,NON-PORS,CALICUM-PHSPHTE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7878448
• Report Number: 1020279-2018-01834
• Device Sequence Number: 174044
• Product Code: MEH
• UDI-Device Identifier: 03596010561497
• UDI-Public: 03596010561497
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2018

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: 01/21/2019
• Device Catalogue Number: 71291302
• Device Lot Number: 09AM17812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 11/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 70 YR