MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LUBINUS SPII HIP PROSTHESIS SYSTEM; LUBINUS SPII HIP STEM

Model Number 127-760/17

Device Problems Fracture (1260); Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

Event Date 05/19/2014

Event Type  malfunction  

Event Description

Breakage of the spii hip stem in the distal area, approx 7.5 years after the implantation.

Manufacturer Narrative

The complaint sample was sent to a laboratory for a visual inspection.We will provide further information when the investigation is complete.This event occurred outside of the u.S.And involves a product that was manufactured outside of the u.S.However, because the affected product is also marketed in the u.S., (b)(4) is submitting this mdr to ensure full compliance with 21 cfr part 803.(b)(4).

• Brand Name: LUBINUS SPII HIP PROSTHESIS SYSTEM
• Type of Device: LUBINUS SPII HIP STEM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; hamburg 2233 9; GM 22339
• Manufacturer Contact: philipp kottmann ; barkhausenweg 10; hamburg 22339 ; GM 22339 ; 053575432
• MDR Report Key: 4272909
• MDR Text Key: 5230970
• Report Number: 3007118403-2014-00004
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K953653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2008
• Device Model Number: 127-760/17
• Device Catalogue Number: 127-760/17
• Other Device ID Number: GMDN: 34190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2003
• 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 Weight: 84