MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECHELON PP HA SZ 13 190MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71342013
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery due to femoral stem breakage below the proximal transition area.Patient complaint of hip pain.
Additional Manufacturer Narrative
Please review attached for the investigation results.[(b)(4)].

• Brand Name: ECHELON PP HA SZ 13 190MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7180677
• Report Number: 1020279-2018-00042
• Device Sequence Number: 13788733
• Product Code: JDI
• UDI-Device Identifier: 03596010479259
• UDI-Public: 03596010479259
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K963486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2018

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: 12/18/2012
• Device Catalogue Number: 71342013
• Device Lot Number: 12KM04842A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2018
• Supplement Date Received by Manufacturer: 01/04/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 03/12/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 84