MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO KG SP II® MODEL LUBINUS®; SP II® MODEL LUBINUS® HIP STEM

Model Number 127-721/26

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Hip Fracture (2349)

Event Type  Injury  

Manufacturer Narrative

Since there is no article and serial number provided the device history cannot be evaluated yet.More information is requested.

Event Description

I have this hip prosthesis in left leg since 2006 and from (b)(6) 2017 until (b)(6) 2018 i´ve has walk with a broken prosthesis.[patient].

Event Description

I have this hip prosthesis in left leg since 2006 and from (b)(6) 2017 until (b)(6) 2018 i´ve has walk with a broken prosthesis.[patient].

Manufacturer Narrative

Since there is no article and serial number available the device history could not be evaluated.This is a legal case and more information or the complaint sample was not provided.The complaint is closed until further information is available.In this case an updated report will be created.The standing time was 12 years.

Event Description

I have this hip prosthesis in left leg since 2006 and from (b)(6) 2017 until (b)(6) 2018 i´ve has walk with a broken prosthesis.[patient].

Manufacturer Narrative

The review of the device history record showed no deviations.All product features corresponded with the valid specifications of the waldemar link gmbh & co.Kg at the time period, when the item was produced.A fracture of the spii hip prosthesis after 12 years of standing time can be confirmed.The x-ray images of 2006 show no failure of implantation.A luxation of the joint prosthesis is visible at the x-ray images of 2011.Furthermore a proximal loosening of cement areas can be assumed by the x-ray images of 2011.This may have caused vibrations of the proximal prosthesis against the fixed distal part of the prosthesis.A fatigue fracture is the outcome.The patient constitution and history may have contributed to the primary loosening and thus to the secondary fracture of the device.Obesity is with regard to our instruction for use a circumstance that can interfere with the success of an operation.According to the documentation review and the investigation results a product or material failure is not assumed.Patient is considered overweight, but her weight is not specified.The complaint samples were not available for an investigation.

• Brand Name: SP II® MODEL LUBINUS®
• Type of Device: SP II® MODEL LUBINUS® HIP STEM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO KG; barkhausenweg 10; hamburg, ; GM
• MDR Report Key: 7826102
• MDR Text Key: 118536076
• Report Number: 3004371426-2018-00009
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• PMA/PMN Number: K953653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2018

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: 04/30/2011
• Device Model Number: 127-721/26
• Device Catalogue Number: 127-721/26
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/02/2018
• Initial Date FDA Received: 08/29/2018
• Supplement Dates Manufacturer Received: 08/02/2018; 08/02/2018
• Supplement Dates FDA Received: 03/29/2019; 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR