MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MODULAR JOINT COMPONENT UNIT - CEMENTABLE INTRACONDYLAR - MEGASYSTEM-C; ROTATING HINGED TOTAL KNEE PROSTHESIS

Model Number 15-8521/25

Device Problems Crack (1135); Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 12/21/2015

Event Type  Injury  

Manufacturer Narrative

The review of the device history record showed no deviations.All product features corresponded with the valid specifications of the waldemar link gmbh & co.Kg at the time, when the item was produced.The reported event is confirmed through investigation.The investigation of the complaint sample showed no deviations and gave no indication which led to a material or manufacturing fault.According to the quality documentation review and the investigation results we exclude a product failure.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

It was reported that a revision surgery was performed due to luxation of the right knee.

• Brand Name: MODULAR JOINT COMPONENT UNIT - CEMENTABLE INTRACONDYLAR - MEGASYSTEM-C
• 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: 8296339
• MDR Text Key: 134706636
• Report Number: 3004371426-2019-00031
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 01/06/2016

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 Expiration Date: 04/30/2015
• Device Model Number: 15-8521/25
• Device Catalogue Number: 15-8521/25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2016
• Date Manufacturer Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2010
• 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: 20 YR
• Patient Weight: 55