MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ROTATIONAL KNEE JOINT PROSTHESIS ENDO-MODEL®, TIBIAL COMPONENT; ROTATING HINGED TOTAL KNEE PROSTHESIS

Model Number 15-8030/11

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 01/15/2015

Event Type  Injury  

Manufacturer Narrative

The visual inspection showed that the pe plateau showed clear pressure marks of the tibia metal component, leading to the conclusion that the pe plateau was not mounted/implanted in the correct position.This leads to micro-movements in the plateau retaining screw.These movements can lead to loosening or even fracture of the plateau screw.The report is delayed due to inconsistencies with regard to foreign event reporting to fda.After re-evaluation of the complaint we determined that it is reportable.We have addressed the inconsistency in reporting foreign events to fda through capa-(b)(4).

Event Description

Translation: inlay fixing screw broken on tibial component.Coupling of the tibial and femoral components was therefore not possible by simple inlay change.

• Brand Name: ROTATIONAL KNEE JOINT PROSTHESIS ENDO-MODEL®, TIBIAL COMPONENT
• Type of Device: ROTATING HINGED TOTAL KNEE PROSTHESIS
• 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: omid rahmatian ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 8296659
• MDR Text Key: 134724636
• Report Number: 3004371426-2019-00006
• 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: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 15-8030/11
• Device Catalogue Number: 15-8030/11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2015
• Initial Date Manufacturer Received: 01/23/2015
• Initial Date FDA Received: 02/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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: 66 YR