MAUDE Adverse Event Report: IMPLANTCAST GMBH AGILON®; METAPHYSEAL COMPONENT TRAUMA 135° INCL. SAFETY SCREW

Model Number 38210001

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 12/16/2021

Event Type  Injury  

Manufacturer Narrative

According the failure description the inverse cap base detached from the metaphyseal component on (b)(6) 2021.A revision operation was necessary.No explants were available for the optical analysis because they were discarded.The production reports and information material of the components were checked and no deviations were found.Regarding of this incident, the attending doctor stated as hypothesis of the root cause that the patient has a history of seizures.Since no further information are available (implant was discarded) it cannot be excluded that the inverse cap was detached due to the consequences of a seizure.By means of the data at hand, a technical cause for this error pattern cannot be determined.

Event Description

The following event was reported to implantcast (b)(4): "the inverse cap base detached from the metaphyseal component.Patient reports no falls or trauma.".

• Brand Name: AGILON®
• Type of Device: METAPHYSEAL COMPONENT TRAUMA 135° INCL. SAFETY SCREW
• Manufacturer (Section D): IMPLANTCAST GMBH; lueneburger schanze 26; buxtehude, 21614 ; GM 21614
• Manufacturer (Section G): IMPLANTCAST GMBH; lueneburger schanze 26; buxtehude, 21614 ; GM 21614
• Manufacturer Contact: frank ansorge ; lueneburger schanze 26; buxtehude, 21614 ; GM 21614
• MDR Report Key: 13314249
• MDR Text Key: 284182525
• Report Number: 3012523063-2022-00001
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 38210001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AGILON® XO INVERSE CAP BASE Ø40MM M
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male