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

Model Number 15-2814/02

Device Problems Positioning Failure (1158); Separation Failure (2547)

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

Event Date 01/23/2024

Event Type  malfunction  

Event Description

Dr.(b)(6) was using an endo model m tibial component (220808/2706) and one of the blind screws for attaching the augment could not be removed and the head got stripped.A second tibial component was opened and a new screwdriver was used but this also had one screw that was locked and could not be removed, leading to this screw head becoming stripped as well.The augment used was then cemented in place and the second tibial component was implanted.Surgery time was extended approximately 15 minutes.Note: the second tibial component is within the scope of recall r-2022-01, but the first tibial component which was opened, and displayed the same issue as the tibial components within the scope of that recall, was manufactured in dec 2022, and therefore is outside the scope of that recall.[customer].

• Brand Name: ENDO MODEL M
• Type of Device: ENDO-M. MOD.ROTATIONKNEE, TIBIAL COMP.,SMALL, NEUTRAL
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 18694246
• MDR Text Key: 336419984
• Report Number: 3004371426-2024-00023
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 15-2814/02
• Device Catalogue Number: 15-2814/02
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2022
• 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 Age: 53 YR
• Patient Sex: Female