MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL; ENDO-MODEL SL, DISTAL FEMORAL REPLACEMENT COMPONENT, RIGHT MEDIUM, UHMWPE, COC

Model Number 16-2855/21

Device Problems Positioning Failure (1158); Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2023

Event Type  malfunction  

Event Description

Poly insert would not engage into the tibial tray during a surgery.[customer].

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

Device used for oncological resection of the right distal femur.Atraumatic component fracture.[customer].

Manufacturer Narrative

The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.For cause investigation - investigation conclusion the imdrf-code d20 was used: cause traced to another device.

Event Description

Poly insert would not engage into the tibial tray during a surgery.[customer].

Manufacturer Narrative

The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.This is the final supplemental report, the complaint is closed.

• Brand Name: ENDO-MODEL SL
• Type of Device: ENDO-MODEL SL, DISTAL FEMORAL REPLACEMENT COMPONENT, RIGHT MEDIUM, UHMWPE, COC
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 17147438
• MDR Text Key: 317356282
• Report Number: 3004371426-2023-00046
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04026575386505
• UDI-Public: 04026575386505
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: 16-2855/21
• Device Catalogue Number: 16-2855/21
• Device Lot Number: 221260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2023
• Initial Date FDA Received: 06/16/2023
• Supplement Dates Manufacturer Received: 11/07/2022; 05/18/2023
• Supplement Dates FDA Received: 08/15/2023; 11/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2022
• 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): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male