MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL PLUS STANDARD; SL-PLUS STD STEM WITH TI/HA 1 NON-CEM

Model Number 11461

Device Problems Metal Shedding Debris (1804); Patient-Device Incompatibility (2682)

Patient Problems Toxicity (2333); Reaction (2414)

Event Date 09/12/2011

Event Type  Injury  

Manufacturer Narrative

For investigation neither the involved component nor details regarding the nature and occurrence of the reported event or relevant medical records were received.Therefore, neither a medical assessment nor a visual inspection of the involved component could be performed.Device history review found no manufacturing or material defects regarding the involved sl-plus stem.Based on the available information, no root cause investigation was feasible and the nature of the complained event remains unclear.This case can be reopened at any time should the involved component or more information relevant for the root cause analysis become available.No corrective and preventive actions have been initiated as a result of the performed investigation.

Event Description

A revision has been reported due to reaction to metal debris.First implantation of a metal on metal hip system from a competitor in 2006.First revision performed in 2006 with replacing of that system to a metal ball head from competitor and sl-plus integration standard stem.

• Brand Name: SL PLUS STANDARD
• Type of Device: SL-PLUS STD STEM WITH TI/HA 1 NON-CEM
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 6340 ; SZ 6340
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau 5000 ; SZ 5000
• Manufacturer Contact: tina mueller ; oberneuhofstrasse 10d; baar; SZ 6340 ; 0628320660
• MDR Report Key: 4395243
• MDR Text Key: 13100556
• Report Number: 9613369-2015-00001
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2012
• Device Model Number: 11461
• Device Catalogue Number: 75002723
• Device Lot Number: 0501.13.0239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2015
• Date Device Manufactured: 02/26/2005
• 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