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

Model Number 15-8022/11

Device Problem Component Incompatible (1108)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

All product features corresponded with the valid specifications of the waldemar link (b)(4) at the time, when the item was produced.For the visual inspection there was one picture of the self-locking and the test screw available.No deviations are visible.The affected tibial component, pe plateau or pictures of the implant were not available for the investigation.Because of that we cannot comprehend the root cause of this failure.It is assumed that something blocked the hole of the pe-plateau during surgery.The implant was checked and assembled with the pe-plateau and trial screw prior shipping, no deviation were noticed.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.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

Self-locking screw could not be placed on the tibial plate component.When trying to place it through the polyethylene insert (uhmwpe), this self-locking screw does not pass, does not screw and does not fix the uhmwpe on the tibial plate.Having to place the trial screw.As a result, the trial screw comes out and the polyethylene insert loses its fixation.

• Brand Name: ROTATIONAL KNEE JOINT PROSTHESIS ENDO-MODEL®
• 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: 8296668
• MDR Text Key: 134726666
• Report Number: 3004371426-2019-00090
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: PE
• 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: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 15-8022/11
• Device Catalogue Number: 15-8022/11
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• 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: 80 YR
• Patient Weight: 70