MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO MODEL; ENDO-M. MOD.ROTATION KNEE,JOINT COMP.UNIT W. PATELLAR FLANGE, SMALL, RIGHT

Model Number 15-2816/11

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/13/2022

Event Type  malfunction  

Manufacturer Narrative

Action being taken by the manufacturer: field safety notice amendment / reinforcement of instructions for use.

Event Description

The screws that are threaded in the tibial base are too tight and it is impossible to loosen them.

• Brand Name: ENDO MODEL
• Type of Device: ENDO-M. MOD.ROTATION KNEE,JOINT COMP.UNIT W. PATELLAR FLANGE, SMALL, RIGHT
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: sagar shetty ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 14559726
• MDR Text Key: 298211908
• Report Number: 3004371426-2022-00020
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K143179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15-2816/11
• Device Catalogue Number: 15-2816/11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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): Other