MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL; CONNECTION COMPONENT

Model Number 16-2840/02

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Fall (1848)

Event Date 10/20/2022

Event Type  Injury  

Event Description

As notified by (b)(6).To complaints on (b)(6) 2022, surgery on (b)(6) 2022, a revision of sl hinge dfr disassociated out of femur.Through text, information as follows: patient fell and twisted knee badly.No fault of implant.X-ray (attached) shows femur was in a great deal of hyper extension.Waiting information on return of explants.Update (b)(6) 2022: notified by the representative that the explanted parts were discarded by the hospital staff although they were intended to be returned.

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

As notified by (b)(6) to complaints on 10/27/2022, surgery on (b)(6) 2022, a revision of sl hinge dfr disassociated out of femur.Through text, information as follows: patient fell and twisted knee badly.No fault of implant.X-ray shows femur was in a great deal of hyper extension.Waiting information on return of explants.Update on 2022-11-04: notified by the representative that the explanted parts were discarded by the hospital staff although they were intended to be returned.[distributor].

• Brand Name: ENDO-MODEL SL
• Type of Device: CONNECTION COMPONENT
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: annerike tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 15769860
• MDR Text Key: 303395725
• Report Number: 3004371426-2022-00045
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04026575359233
• UDI-Public: 04026575359233
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Model Number: 16-2840/02
• Device Catalogue Number: 16-2840/02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/28/2022
• Initial Date FDA Received: 11/10/2022
• Supplement Dates Manufacturer Received: 10/28/2022
• Supplement Dates FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• 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 Sex: Female