MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR PLUS HA HO STEM SZ 14; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCMNTD, METAL/POLYMER, NON-POROUS, C-P

Catalog Number	71309114
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	09/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implantation date is an estimate because only the year was provided.
Event or Problem Description
It was reported that a revision surgery of the left hip was performed due to a peri prosthetic fracture of the proximal femur.Femoral stem, femoral head and liner were removed and replaced.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.Please see attached file for our results of investigation.(b)(4).

• Brand Name: SYN POR PLUS HA HO STEM SZ 14
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCMNTD, METAL/POLYMER, NON-POROUS, C-P
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6874628
• Report Number: 1020279-2017-00755
• Device Sequence Number: 1221446
• Product Code: MEH
• UDI-Device Identifier: 03596010459794
• UDI-Public: 03596010459794
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K002996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2017

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 Catalogue Number: 71309114
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 09/18/2017
• Supplement Report FDA Received Date: 11/10/2017
• 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: 85 YR