MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG CUSTOMLINK; STEM SEGMENT

Model Number 15-8522/10

Device Problems Degraded (1153); Fracture (1260); Unstable (1667)

Patient Problems Failure of Implant (1924); Hyperextension (4523)

Event Date 11/22/2022

Event Type  Injury  

Event Description

Lateral femoral instability.

Manufacturer Narrative

The affected article is not approved in the usa, since it is a custom-made device.There is no pma or 510(k).This is the final supplemental report, the complaint is closed.

Event Description

Lateral femoral instability.

• Brand Name: CUSTOMLINK
• Type of Device: STEM SEGMENT
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 16144909
• MDR Text Key: 307153587
• Report Number: 3004371426-2023-00001
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K151008
• 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: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 15-8522/10
• Device Catalogue Number: 15-8522/10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR