MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG REPLACEMENT SET FOR ENDO-MODEL ROTATION KNEE JOINT PROSTHESIS ROTATING HINGED TOTAL KNEE PROSTHESIS

Model Number 99-0027/12

Device Problems Unstable (1667); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 05/09/2019

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 (b)(4) at the time, when the item was produced. Further information and the explanted components were requested.

Event Description

It was reported that a revision surgery was performed due to knee instability.

• Brand Name: REPLACEMENT SET FOR ENDO-MODEL ROTATION KNEE JOINT PROSTHESIS
• 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: 8691143
• MDR Text Key: 147727705
• Report Number: 3004371426-2019-00124
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K821476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 01/31/2019
• Device Model Number: 99-0027/12
• Device Catalogue Number: 99-0027/12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/12/2019 Patient Sequence Number: 1