MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINK® ENDO-MODEL ROTATION KNEE JOINTP.,PAT. FLANGE,ANTI-LUX.,MEDIUM, RIGHT; ROKNEP M. LUX.SICH. U. PAT., M

Model Number	15-8024/11#02
Medical Device Problem Code	Unclear Information (4052)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The production records have been inspected and reviewed.The error has not been detected.
Event or Problem Description
We have identified a traceability problem internally, regarding this serial number and the corresponding marking on the item.
Event or Problem Description
We have identified a traceability problem internally, regarding this serial number and the corresponding marking on the item.
Additional Manufacturer Narrative
The production records have been inspected and reviewed.The error has not been detected.This report is the final supplemental report, the complaint ist closed.

• Brand Name: LINK® ENDO-MODEL ROTATION KNEE JOINTP.,PAT. FLANGE,ANTI-LUX.,MEDIUM, RIGHT
• Common Device Name: ROKNEP M. LUX.SICH. U. PAT., M
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 17623883
• Report Number: 3004371426-2023-00095
• Device Sequence Number: 6119085
• Product Code: KRO
• UDI-Device Identifier: 04026575048045
• UDI-Public: 04026575048045
• Combination Product (Y/N): N
• Initial Reporter Country: BU
• PMA/510(K) Number: K143179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 15-8024/11#02
• Device Catalogue Number: 15-8024/11#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: 08/18/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 11/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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
• Patient Sex: Unknown