MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM; FEMORAL SPACER, S4,80 MM, SMALL, LEFT,ENDO-M. MODUL. KNEEP. SYSTEM

Model Number 15-2964/02

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Bone Shedding Debris (4557)

Event Date 06/06/2023

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

The patient's follow-up visit notes were sent to linkbio on 2023-06-28.The most recent follow-up visit note dated (b)(6) 2023 indicates that the patient has distal femur pain with radiographic studies showing loosening of the femoral cement mantle and stem, which dr.(b)(6) thinks may be resulting from the polyethylene augment that she has on the femoral side.Dr.(b)(6) plans to revise the femoral side with a custom design.[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

The most recent follow-up visit note dated (b)(6) 2023 indicates that the patient has distal femur pain with radiographic studies showing loosening of the femoral cement mantle and stem.[customer].

• Brand Name: ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM
• Type of Device: FEMORAL SPACER, S4,80 MM, SMALL, LEFT,ENDO-M. MODUL. KNEEP. SYSTEM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 17403279
• MDR Text Key: 319835163
• Report Number: 3004371426-2023-00055
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04026575205875
• UDI-Public: 04026575205875
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211768
• 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: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 15-2964/02
• Device Catalogue Number: 15-2964/02
• Device Lot Number: 2131015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2021
• 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: 64 YR
• Patient Sex: Female
• Patient Weight: 69 KG