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

Model Number 15-8022/12

Device Problem Break (1069)

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.The femoral component and the pe-plateau were provided for the visual inspection.The rotational bushing and the extension buffer are damaged.The backside of the pe-plateau is intact whereas the anti-luxation device is damaged.A damage pattern as in the present case is known from cases of damage after functional overload of the components.Both the user guide and the surgical technique provide sufficient information to the user to ensure a safe application of the products.The publications nieder (1991) and katzer (2002) described the failure mechanism in detail and put emphasis on the correct indication for this prosthesis.The implant standing time was 2 years.No patient information, surgery reports and preoperative x-rays images were provided for the investigation.According to the quality documentation review and the investigation results a product failure is not assumed.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

Prosthesis described as "seizing up" by surgeon, suspected bushing failure, poly was worn inside mechanism when removed, no obvious malrotation or hyperextension, both stems appeared to be well fixed.Femoral component and tibial plateau were revised.

• 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: 8296677
• MDR Text Key: 134723550
• Report Number: 3004371426-2019-00099
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/31/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2017
• Device Model Number: 15-8022/12
• Device Catalogue Number: 15-8022/12
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2012
• 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