MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG CONNECTION COMPONENT CEMENTLESS ROTATIONAL VERSION - V02 ROTATIONAL KNEE SL

Model Number 16-2840/05

Device Problems Positioning Failure (1158); Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)

Event Date 09/07/2017

Event Type  malfunction  

Manufacturer Narrative

All product features correspond with the valid specifications of the waldemar link at the time, when the item was produced.This mdr is preventive action.Until now only the complaint sample was returned to us for further investigation.The user was contacted to receive more information e.G.X-ray images, surgery report without response.We will provide further information as soon as the investigation continues.

Event Description

Rotational connection component dislocated about 1 year after implanted.Did not appear to have screw flush.Patient outcome is fine.Explant was returned to manufacturer for investigation.

Manufacturer Narrative

All product features corresponded with the valid specifications of the waldemar link gmbh & co.Kg at the time, when the item was produced.This mdr is preventive action.Until now only the complaint sample was returned to us for further investigation.The user was contacted to receive more information e.G.X-ray images, surgery report without response.We will provide further information as soon as the investigation continues.

Event Description

Rotational connection component dislocated about 1 year after implanted.Did not appear to have screw flush.Patient outcome is fine.Explant was returned to manufacturer for investigation.

• Brand Name: CONNECTION COMPONENT CEMENTLESS ROTATIONAL VERSION - V02 ROTATIONAL KNEE SL
• Type of Device: CONNECTION COMPONENT CEMENTLESS ROTATIONAL VERSION - V02 ROTATIONAL KNEE SL
• 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: 6921986
• MDR Text Key: 89592634
• Report Number: 3004371426-2017-00004
• 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,Followup
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Model Number: 16-2840/05
• Device Catalogue Number: 16-2840/05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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