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
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924); Pain (1994)
Date of Event	11/02/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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].
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3004371426-2023-00078
• Device Sequence Number: 6125875
• Product Code: KRO
• UDI-Device Identifier: 04026575034741
• UDI-Public: 04026575034741
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K212742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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 Expiration Date: 09/30/2026
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 109 KG