MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL PLUS LATERAL; SL-PLUS STEM LATERAL 2 NON-CEMENTED

Model Number 11532

Device Problem Metal Shedding Debris (1804)

Patient Problem No Code Available (3191)

Event Date 09/03/2008

Event Type  Injury  

Event Description

A revision of the hip has been reported due to reaction of metal debris.

• Brand Name: SL PLUS LATERAL
• Type of Device: SL-PLUS STEM LATERAL 2 NON-CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 6340 ; SZ 6340
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau 5001 ; SZ 5001
• Manufacturer Contact: claudia odoy ; oberneuhofstrasse 10d; baar; SZ 6340 ; 0628320660
• MDR Report Key: 4534793
• MDR Text Key: 5505214
• Report Number: 9613369-2015-00011
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K021178
• 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: 02/23/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2013
• Device Model Number: 11532
• Device Catalogue Number: 75002749
• Device Lot Number: 0602.13.1307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2015
• Initial Date FDA Received: 02/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/15/2015
• Date Device Manufactured: 02/01/2005
• 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
• Treatment: COMPETITORS PRODUCTS
• Patient Outcome(s): Hospitalization; Required Intervention