MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MEGA SYSTEM C; CONNECTION COMPONENT

Model Number	16-2840/02
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Connection problem.
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.
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 the revision surgery referenced in distributor´s complaint (b)(4) , the surgeon experienced significant difficulty in seating the bushings of the rotating hinge connection component into the bearing with two separate implants.Of note, this was the surgeon's first time using this system, hence the attendance in the surgery by distributor´s personnel.Also, this was a complex revision case, as it was a revision to a mega c sl push through total femur.In the first attempt to insert the connection component, one side would not fully seat and the surgeon attempted multiple times to seat the implant and get the spring to advance enough to deploy fully.During these attempts, he pulled the connection component out too far and the device sprang apart.Following this, a new connection component was taken and the surgeon experienced the same difficulty in fully deploying the spring on the same side, and this device was also was pulled back too far and accidentally allowed to spring apart.The surgeon reassembled the device under the guidance of the distributor´s employee as there was no third connection component available for the surgery.The team then concluded that the bearing had become deformed in the multiple attempts to seat the connection component.A replacement bearing box was then installed, and the connection component was able to be fully seated with full deployment of the spring.[sales rep.].

• Brand Name: MEGA SYSTEM C
• Common Device Name: CONNECTION COMPONENT
• 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: 16685919
• Report Number: 3004371426-2023-00021
• Device Sequence Number: 12586216
• Product Code: KRO
• UDI-Device Identifier: 04026575359233
• UDI-Public: 04026575359233
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K151008
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2023

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
• Operator of Device: Health Professional
• Device Model Number: 16-2840/02
• Device Catalogue Number: 16-2840/02
• 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: 03/06/2023
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 136 KG