MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL ROTATIONAL KNEE PROSTHESIS; REPLACEMENT SET LINK TIBIA PLATEAU V02

Model Number 15-0027/16

Device Problem Component Incompatible (1108)

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

Event Date 09/27/2018

Event Type  malfunction  

Manufacturer Narrative

The quality records have been reviewed and checked.A visual examination confirms the incorrect packaging of the tibial plateaus.There were two plateaus with pinhole design in the package, instead of 1 x pinhole and 1 x dovetail design.Two sets were manufactured in this production order.In the second set, the counterparts with dovetail design could be ensured.It is a one-to-one substitution.The cause is a human error.The warehouse stock has been checked and no further faulty sets have been identified.To prevent this error, a corrective and preventive action has been initiated and an engineering change introduced for an additional quality control.The employees are trained in this regard.The waldemar link (b)(4) is aiming for the highest product quality and trying to keep the failure rate as low as possible by means of the customer feedback.Permanent employee trainings and market surveillance are performed.

Event Description

There were only two pe plateaus with pinhole design in the packaging.No dovetail design [(b)(6) hospital].

• Brand Name: ENDO-MODEL ROTATIONAL KNEE PROSTHESIS
• Type of Device: REPLACEMENT SET LINK TIBIA PLATEAU V02
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer (Section G): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: annerike kleine ; barkhausenweg 10; hamburg, ; GM
• MDR Report Key: 8008168
• MDR Text Key: 126379664
• Report Number: 3004371426-2018-00014
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 15-0027/16
• Device Catalogue Number: 15-0027/16
• Device Lot Number: 1836025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Date Manufacturer Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1