MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MEGASYSTEM-C; LINK FEMORAL COMPONENT INTRACONDYLAR MEGASYSTEM-C

Model Number 15-8521/36

Device Problems Off-Label Use (1494); Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 03/24/2023

Event Type  Injury  

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 Description

Surgeon put the femoral component back on the stem, but it came apart for a second time.Surgeon then revised it to a longer mega c dfr [customer].

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 Description

Surgeon put the femoral component back on the stem, but it came apart for a second time.Surgeon then revised it to a longer mega c dfr [customer.].

• Brand Name: MEGASYSTEM-C
• Type of Device: LINK FEMORAL COMPONENT INTRACONDYLAR MEGASYSTEM-C
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 16780403
• MDR Text Key: 313685107
• Report Number: 3004371426-2023-00019
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04026575386512
• UDI-Public: 04026575386512
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K143179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

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 Operator: Health Professional
• Device Model Number: 15-8521/36
• Device Catalogue Number: 15-8521/36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 03/27/2023
• Supplement Dates FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention