MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG CONNECTION COMPONENT ROTATIONAL VERSION, SMALL

Model Number 16-2840/02

Device Problem Detachment Of Device Component (1104)

Patient Problem Fall (1848)

Event Date 11/02/2017

Event Type  malfunction  

Manufacturer Narrative

All product features corresponded with the valid specifications of the waldemar link (b)(4) at the time, when the item was produced.Both the user guide and the surgical technique provide sufficient information to the user to ensure a safe application of the product.Until now the complaint sample was not returned to us for further investigations.So an exact root cause for the reported problem cannot be determined.The user was contacted to receive more information e.G.X-ray images, surgery report, complaint sample, without response.We will provide further information as soon as the investigation continues.

Event Description

This is an endo modell sl distal femoral hinged knee dislocation.The hinge has dis-engaged from the distal femur.Hinged bushings show damage.The hinge appears to have stayed in place of the tibial implant with decoupling of the distal femur of the hinge.Patient felt a snap and fell.Presented to er same day and was scheduled for revision surgery.

• Brand Name: CONNECTION COMPONENT ROTATIONAL VERSION, SMALL
• Type of Device: CONNECTION COMPONENT ROTATIONAL VERSION, SMALL
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer (Section G): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; 22339 ; GM 22339
• Manufacturer Contact: lennard ahlborn ; barkhausenweg 10; GM 22339
• MDR Report Key: 7120746
• MDR Text Key: 95532262
• Report Number: 3004371426-2017-00005
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K151008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/01/2021
• Device Model Number: 16-2840/02
• Device Catalogue Number: 16-2840/02
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2016
• 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: 43 YR
• Patient Weight: 73