MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL-M; ENDO-M. MOD.ROTATION KNEE, TIBIAL COMP., MEDIUM, NEUTRAL

Model Number 15-2814/03

Device Problems Component Incompatible (1108); Nonstandard Device (1420)

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

Event Date 08/02/2022

Event Type  malfunction  

Event Description

Uhmwpe tibial plateau has not allowed the associated fixation screw to pass through it.In this instance the surgeon used a burr to bore the hole out further and allow the screw to go through.

Manufacturer Narrative

The review of the device history record showed no deviations.

Manufacturer Narrative

The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.

Event Description

Uhmwpe tibial plateau has not allowed the associated fixation screw to pass through it.In this instance the surgeon used a burr to bore the hole out further and allow the screw to go through.

• Brand Name: ENDO-MODEL-M
• Type of Device: ENDO-M. MOD.ROTATION KNEE, TIBIAL COMP., MEDIUM, NEUTRAL
• 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: 15273436
• MDR Text Key: 300571321
• Report Number: 3004371426-2022-00032
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15-2814/03
• Device Catalogue Number: 15-2814/03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2022
• 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