MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYNERGY POR HO FEM COM SZ 16; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL

Catalog Number	71306116
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/05/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a right hip revision surgery was performed due to periprosthetic fracture of the patient's femur as a result of the patient falling on the operative side.Stem was removed during the revision surgery.
Additional Manufacturer Narrative
Please review attached for the investigation results.(b)(4).

• Brand Name: SYNERGY POR HO FEM COM SZ 16
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6566901
• Report Number: 1020279-2017-00340
• Device Sequence Number: 19095090
• Product Code: MRA
• UDI-Device Identifier: 03596010292001
• UDI-Public: 03596010292001
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2017

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: 08/15/2019
• Device Catalogue Number: 71306116
• Device Lot Number: 09HM09872
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2017
• Supplement Date Received by Manufacturer: Not provided; 04/19/2017
• Initial Report FDA Received Date: 05/15/2017
• Supplement Report FDA Received Date: 05/17/2017; 09/29/2017
• 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: FEMORAL HEAD PART# 71303604 LOT# UNKNOWN; LINER PART# 71332756 LOT# UNKNOWN; SHELL PART# 71335556 LOT# UNKNOWN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 68