MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; PK-ORTHO-TKA

Catalog Number	DYNJ48388F
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The account reported finding rusted blades.A photo was received for the investigation; per evaluation of the received photo, the number 10 blade is shown without the packaging and there is a light brown discoloration on the edge of the blade and on the tip of the blade, and no other defects or damage was observed.Finished good production records and finished good pack build were reviewed, and there were no issues identified that likely contributed to the reported issue; per the photos that were received, the reported issue was confirmed.Due to the staining being on the edge of the blade, the root cause is considered to be a vendor product issue relating to the component manufacturing process, and the complaint was provided to the component manufacturing facility for further evaluation while supplier quality will monitor this issue for trending purposes.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.
Event or Problem Description
It was reported that rust on blades.

• Brand Name: MEDLINE
• Common Device Name: PK-ORTHO-TKA
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nicholas kourkine ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50715548
• Report Number: 1417592-2026-35824
• Device Sequence Number: 10640554
• Product Code: OJH
• UDI-Device Identifier: 40195327204335
• UDI-Public: 40195327204335
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/06/2026

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
• Device Catalogue Number: DYNJ48388F
• Device Lot Number: 22HBW084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown