MAUDE Adverse Event Report: WALDEMAR LINK GMBH&CO.KG MEGASYSTEM C; FEMORAL COMPONENTS,CONDYLAR REPLACEMENTLINK MEGASYSTEM-C,MEDIUM, RIGHT

Model Number	15-8521/10
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
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
During surgery last week, the surgeon wanted to use implant 15-8521/10 lot 200113/1159 07/25 but was unpleasantly surprised to find that the sterile bag had been punctured.The cardboard packaging of the implant was not damaged.[customer].
Event or Problem Description
During surgery last week, the surgeon wanted to use implant 15-8521/10 lot 200113/1159 07/25 but was unpleasantly surprised to find that the sterile bag had been punctured.The cardboard packaging of the implant was not damaged.
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.This is the final supplemental report, the complaint is closed.

• Brand Name: MEGASYSTEM C
• Common Device Name: FEMORAL COMPONENTS,CONDYLAR REPLACEMENTLINK MEGASYSTEM-C,MEDIUM, RIGHT
• Manufacturer (Section D): WALDEMAR LINK GMBH&CO.KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 17369330
• Report Number: 3004371426-2023-00054
• Device Sequence Number: 3715347
• Product Code: KRO
• UDI-Device Identifier: 04026575381753
• UDI-Public: 04026575381753
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K143179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/22/2023

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
• Device Expiration Date: 07/31/2025
• Device Model Number: 15-8521/10
• Device Catalogue Number: 15-8521/10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2020
• 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