MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO.KG ENDO-MODEL® - M, ROTATIONAL KNEE PROSTHESIS; ROTATIONAL KNEE PROSTHESIS, MODULAR STEM, WITH ADDITIONAL TABS, COCRMO/TINBN

Model Number 15-3950/06

Device Problems Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994)

Event Date 08/14/2023

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 had a link hinge knee implanted on (b)(6) 2022 and subsequently underwent revision knee surgery on (b)(6) 2023 (reported previously in complaint: (b)(4).The patient subsequently experienced pain.No cause was evident on x-rays.The patient underwent revision surgery on (b)(6) 2023.Presence of reactive tissue was noted.The cause is unknown, but according to the sales rep, the surgeon suspected potential infection or potential allergy to cement.When the doctor flexed the knee, the femur component, which had been fixed to the bone via cementing of the conical stem and 50mm uhmwpe distal femur augment, came loose from the cement.All knee components were then replaced during the 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

The patient had a link hinge knee implanted (b)(6) 2022 and subsequently underwent revision knee surgery on (b)(6) 2023 (reported previously in complaint (b)(4).The patient subsequently experienced pain.No cause was evident on x-rays.The patient underwent revision surgery on (b)(6) 2023.Presence of reactive tissue was noted.The cause is unknown, but according to the sales rep, the surgeon suspected potential infection or potential allergy to cement.When the doctor flexed the knee, the femur component, which had been fixed to the bone via cementing of the conical stem and 50mm uhmwpe distal femur augment, came loose from the cement.All knee components were then replaced during the surgery [customer].

• Brand Name: ENDO-MODEL® - M, ROTATIONAL KNEE PROSTHESIS
• Type of Device: ROTATIONAL KNEE PROSTHESIS, MODULAR STEM, WITH ADDITIONAL TABS, COCRMO/TINBN
• 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: 17785550
• MDR Text Key: 323894590
• Report Number: 3004371426-2023-00092
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212742
• 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: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 15-3950/06
• Device Catalogue Number: 15-3950/06
• Device Lot Number: 2164333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2021
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 117 KG