MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL; MODULAR STEMS, WITH FEMALE TAPER

Model Number 15-8515/55

Device Problems Osseointegration Problem (3003); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 12/20/2022

Event Type  Injury  

Event Description

Dr.Revised the patient's loosened tibial component and stem.These components were originally implanted on (b)(6) 2016.The patient has undergone several subsequent revisions of other parts of the total knee replacement (documented in complaints: (b)(4).This tibial tray and stem (implanted 2016) were revised to a custom-made tibial implant (cus-690) on (b)(6) 2022.Per dr., the cause of the loosened tibia was "terrible bone stock.Too small a diameter stem and probably not long enough as well.

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

The patient had undergone several prior revisions following revision total knee replacement performed in (b)(6) 2016, with preceding history or limb salvage surgery and infected total knee arthroplasty.This tibial tray and stem (implanted in 2021) were revised to a custom-made implant.Per dr.M., the cause of the loosened tibia was "terrible bone stock.Too small a diameter stem and probably not long enough as well.".

• Brand Name: ENDO-MODEL SL
• Type of Device: MODULAR STEMS, WITH FEMALE TAPER
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 16172827
• MDR Text Key: 307491683
• Report Number: 3004371426-2023-00002
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04026575384006
• UDI-Public: 04026575384006
• 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: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 15-8515/55
• Device Catalogue Number: 15-8515/55
• Device Lot Number: 1816112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2018
• 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: 67 YR
• Patient Sex: Male