MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL® ROTATIONAL KNEE PROSTHESIS SL, FEMORAL COMPONENT LEFT

Model Number 16-2823/22

Device Problems Positioning Failure (1158); Device Operates Differently Than Expected (2913); Material Deformation (2976); Material Protrusion/Extrusion (2979)

Patient Problems Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 08/10/2017

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

Femoral preoperation: implantation went well.Tibial preoperation: implantation went well.Connection component malfunctioned, expanding the component into the femur was not possible.The tibial was placed in a lot of external rotation so engaging the component into the femur was very difficult.In so doing, the poly bushings in the femoral condyles kept coming out, and deforming.We attempted several times to put them back, but connection component would not engage.Opened a new femur and used the bushings from that one and a new connection component.Patient outcome is fine.Explant was returned to manufacturer for investigation.

Manufacturer Narrative

This mdr is preventive action.Until now only the femoral component was returned to us for further investigation.The user was contacted to receive more information e.G.X-ray images, surgery report without response.Both the user guide and the surgical technique provide sufficient information to the user to ensure a safe application of the product.All product features corresponded with the valid specifications of the (b)(4) at the time, when the item was produced.We will provide further information as soon as the investigation continues.

Event Description

Femoral preperation: implantation went well.Tibial preperation: implantation went well.Connection component mailfunctioned, expanding the component into the femur was not possible.The tibial was placed in a lot of external rotation so engaging the component into the femur was very difficult.In so doing, the poly bushings in the femoral condyles kept coming out, and deforming.We attempted several times to put them back, but connection component would not engage.Opened a new femur and used the bushings from that one and a new connection component.Patient outcome is fine.Explant was returned to manufacturer for investigation.

Manufacturer Narrative

Removal of "required intervention to prevent permanent impairment/damage" after re-evaluation of the complaint we determined that the problem occured intraoperatively, no medical intervention was required.Additional information all product features corresponded with the valid specifications of the waldemar link gmbh & co.Kg at the time, when the item was produced.The visual inspection showed no abnormalities of the femoral component.The bearing inserts are deformed upon receipt.It was possible to assemble the femoral component with an identically constructed connection component.The femoral component was returned to us for further investigation.The claimed connection component was not available for examination.As the x-ray images and surgery reports were not provided, we have not been able to conduct a comprehensive investigation to determine the root cause in this case.The user was contacted to receive more information e.G.X-ray images, surgery report without response.Both the user guide and the surgical technique provide sufficient information to the user to ensure a safe application of the product.

• Brand Name: ENDO-MODEL® ROTATIONAL KNEE PROSTHESIS SL, FEMORAL COMPONENT LEFT
• Type of Device: ENDO-MODEL® ROTATIONAL KNEE PROSTHESIS SL, FEMORAL COMPONENT LEFT
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 6900236
• MDR Text Key: 89481775
• Report Number: 3004371426-2017-00003
• 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,Followup
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2021
• Device Model Number: 16-2823/22
• Device Catalogue Number: 16-2823/22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention