MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO.KG ENDO-MODEL- M, ROTATIONAL KNEE PROSTHESIS; KNEE-JOINT PROSTHESIS RIGHT, SMALL, COCRMO/TINBN, WITH PATELLAR FLANGE

Model Number 15-3816/11#02

Device Problems Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problems Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924); Pain (1994)

Event Date 11/02/2023

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

Tinbn-coated hinged knee was implanted (b)(6) 2022 as a temporary spacer for the 1st stage in a planned 2 stage revision for infection.This tinbn-coated hinged knee was used as a spacer because of the patient's nickel allergy.The patient underwent revision surgery (b)(6) 2022.The femoral component, tibial polyethylene bearing, and femoral augment were replaced (impacted onto the existing femoral stem in situ).Prior surgeries on this knee include: primary and revision tka (not link product), revision with link compassionate use components (b)(6)2022(comp(b)(4)), and subsequent revisions (b)(6) 2022 and (b)(6) 2022 for infection (previously reported in complaint (b)(4)).[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

Tinbn-coated hinged knee was implanted (b)(6) 2022 as a temporary spacer for the 1st stage in a planned 2 stage revision for infection.This tinbn-coated hinged knee was used as a spacer because of the patient's nickel allergy.The patient underwent revision surgery (b)(6) 2022.The femoral component, tibial polyethylene bearing, and femoral augment were replaced (impacted onto the existing femoral stem in situ).Prior surgeries on this knee include: primary and revision tka (not link product), revision with link compassionate use components (b)(6) 2022 ((b)(4)), and subsequent revisions (b)(6) 2022 and (b)(6) 2022 for infection (previously reported in (b)(4)).[customer].

• Brand Name: ENDO-MODEL- M, ROTATIONAL KNEE PROSTHESIS
• Type of Device: KNEE-JOINT PROSTHESIS RIGHT, SMALL, COCRMO/TINBN, WITH PATELLAR FLANGE
• 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: 17602032
• MDR Text Key: 321717286
• Report Number: 3004371426-2023-00078
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04026575034741
• UDI-Public: 04026575034741
• 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: 07/26/2023

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 Model Number: 15-3816/11#02
• Device Catalogue Number: 15-3816/11#02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/23/2023
• Supplement Dates Manufacturer Received: 07/26/2023
• Supplement Dates FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 109 KG