MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL; FEMORAL COMPONENT, INTRACONDYLAR MODULAR CEMENTED ROTATIONAL KNEE

Model Number 16-2825/21

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 05/19/2021

Event Type  Injury  

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

Disconnection between femoral component and stem [customer].

Event Description

Disconnection between femoral component and stem [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

Disconnection between femoral component and stem [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.Correction #2: date explanted: (b)(6) 2021.

• Brand Name: ENDO-MODEL SL
• Type of Device: FEMORAL COMPONENT, INTRACONDYLAR MODULAR CEMENTED ROTATIONAL KNEE
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 12274314
• MDR Text Key: 264965092
• Report Number: 3004371426-2021-00023
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K151008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2021

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: 01/31/2021
• Device Model Number: 16-2825/21
• Device Catalogue Number: 16-2825/21
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/04/2021
• Supplement Dates Manufacturer Received: 07/29/2021; 07/29/2021
• Supplement Dates FDA Received: 08/19/2021; 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR