MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS MIA STEM 01 NON-CEM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number 75001937

Device Problems Loose or Intermittent Connection (1371); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 07/08/2014

Event Type  Injury  

Event Description

Sl-plus mia stem / revision due to aseptic loosening after 1y 4m-- revision surgery was performed due to stem loosening. the surgeon of revision surgery said that the cause of this loosening was mismatch between stem and patient¿s bone geometry.(mischoice by the surgeon of primary surgery).The revision surgeon does not fault the device.

Manufacturer Narrative

This medical device report (mdr) is being submitted by smith & nephew as part of corrective actions following the issuance of the 483 issued march 3, 2015 to smith & nephew orthopaedics ag, fei no: (b)(4).This complaint has been re-assessed in accordance under the provisions of 21c.F.R.§803.50 and deemed reportable as an mdr.We are submitting one (1) initial, 30 day report, medwatch fda form 3500a.

• Brand Name: SL-PLUS MIA STEM 01 NON-CEM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau 5001
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau 5001 ; SZ 5001
• Manufacturer Contact: claudia odoy ; 0628320660
• MDR Report Key: 4627901
• MDR Text Key: 5588548
• Report Number: 9613369-2015-00021
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 07/10/2014

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: 07/25/2019
• Device Model Number: 75001937
• Device Catalogue Number: 75001937
• Device Lot Number: B1210714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/08/2014
• Initial Date FDA Received: 03/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2015
• Date Device Manufactured: 07/26/2012
• 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: (B)(4) CERAMIC CERAMIC BALL HEAD 32M
• Patient Outcome(s): Hospitalization; Required Intervention