MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO MODEL SL CONNECTION COMPONENT ROTATIONAL VERSION; ROTATING HINGED TOTAL KNEE PROSTHESIS

Model Number 16-2840/02

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

The review of the device history record showed no deviations.All product features corresponded with the valid specifications of the (b)(4) at the time, when the item was produced.The reason for the reported loosening of the screw cannot be determined with the available information.Further information was requested but not provided.It is unknown whether the screw was tightened with the torque wrench hex screwdriver during implantation.We will reopen the investigation if further information is available.

Event Description

During a surgical procedure for patella clicking and to implant a patella the surgeon noticed that the screw on the hinge device was loose.It took the surgeon at least 3-4 turns to get the screw tight.

• Brand Name: ENDO MODEL SL CONNECTION COMPONENT ROTATIONAL VERSION
• Type of Device: ROTATING HINGED TOTAL KNEE 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: 8686295
• MDR Text Key: 147604282
• Report Number: 3004371426-2019-00123
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 16-2840/02
• Device Catalogue Number: 16-2840/02
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2017
• 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 Age: 71 YR