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

Device Problem Unintended Movement (3026)

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Date 09/06/2017

Event Type  Injury  

Manufacturer Narrative

Implantation date is an estimate because only the year was provided.

Event 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.

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
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCMNTD, METAL/POLYMER, NON-POROUS, C-P
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 6874628
• MDR Text Key: 86553684
• Report Number: 1020279-2017-00755
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03596010459794
• UDI-Public: 03596010459794
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K002996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71309114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85 YR