MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LUBINUS SP II HIP PROSTHESIS STEM - LONG; REVISION UNCOATED HIP FEMUR PROSTHESIS

Model Number 127-923/35

Device Problems Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Fall (1848); Failure of Implant (1924)

Event Date 07/25/2017

Event Type  Injury  

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, when the item was produced.The stem was available for visual examination.A fracture of the stem can be confirmed, this was 150 mm above the stem tip.The investigation has shown that it is a fatigue fracture.The investigations did not reveal material-specific errors.The report is delayed due to inconsistencies with regard to foreign event reporting to fda.After re-evaluation of the complaint we determined that it is reportable.We have addressed the inconsistency in reporting foreign events to fda through capa-(b)(4).

Event Description

It was reported that the stem was fractured.

• Brand Name: LUBINUS SP II HIP PROSTHESIS STEM - LONG
• Type of Device: REVISION UNCOATED HIP FEMUR PROSTHESIS
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: rebekka winterhoff ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 8296400
• MDR Text Key: 134708575
• Report Number: 3004371426-2019-00084
• 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: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2010
• Device Model Number: 127-923/35
• Device Catalogue Number: 127-923/35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2005
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 89