MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR PLUS HA SO STEM SZ 11; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CA-P

Model Number	71309011
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Hip Fracture (2349); No Code Available (3191)
Date of Event	06/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant date is an approximation based on patient's memory that it occured some 7 years ago.
Event or Problem Description
It was reported that patient underwent revision surgery due to periprosthetic fracture.The surgeon's first choice was a cable because of the patients age.Stem was noticed to be loose because of the fracture.
Additional Manufacturer Narrative
Corrections based on additional information received.
Additional Manufacturer Narrative
Correction based on new data received.
Additional Manufacturer Narrative
Please see attached file for our results of investigation.(b)(4).

• Brand Name: SYN POR PLUS HA SO STEM SZ 11
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CA-P
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6709789
• Report Number: 1020279-2017-00526
• Device Sequence Number: 11154566
• Product Code: MEH
• UDI-Device Identifier: 03596010459664
• UDI-Public: 03596010459664
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K002996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/13/2017

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 Model Number: 71309011
• Device Catalogue Number: 71309011
• Device Lot Number: 08BM14976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Initial Date Received by Manufacturer: 06/15/2017
• Supplement Date Received by Manufacturer: 07/13/2017; 07/28/2017; 07/28/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 07/17/2017; 08/07/2017; 10/13/2017
• 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: UNKNOWN OXINIUM FEMORAL HEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR