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

Model Number	15-3816/11
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
In a request form from dr.M for compassion use revision, reference (b)(4), the doctor mentions that he suspected that the poly augments implanted on (b)(6) 2021 may be loose.Received the post-op report on (b)(6)2025, stating that the tibial component showed evidence of loosening, the femoral component did not.The tibial component was undercut below the level of the poly augment.Revision with (b)(4) was completed on (b)(6) 2024.Unknown date of event.Pre-op and post-op imaging has been requested.
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
In a request form from dr.M for compassion use revision, reference (b)(4), the doctor mentions that he suspected that the poly augments implanted on (b)(6) 2021, may be loose.Received the post-op report on 01/10/2025, stating that the tibial component showed evidence of loosening, the femoral component did not.The tibial component was undercut below the level of the poly augment.Revision with (b)(4) was completed on oct.2, 2024.Unknown date of event.Pre-op and post-op imaging has been requested.
Additional Manufacturer Narrative
The review of the history record showed no deviations.The product complies with the specifications valid at the time of manufacture.This is the final supplemental report.The complaint is closed.

• Brand Name: ENDO MODEL M
• Common Device Name: ROTATIONAL KNEE PROSTHESIS, KNEE-JOINT PROSTHESIS RIGHT, SMALL, COCRMO/TINBN
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: tizia hucklenbroch ; barkhausenweg 10; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 21320855
• Report Number: 3004371426-2025-00003
• Device Sequence Number: 18174994
• 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: K152431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• 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): 01/13/2025

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
• Operator of Device: Health Professional
• Device Model Number: 15-3816/11
• Device Catalogue Number: 15-3816/11
• 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: 02/12/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 117 KG