MAUDE Adverse Event Report: IMPLANTCAST GMBH AGILON®; STEM CEMENTLESS Ø18/60MM

Model Number 38506018

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 06/22/2022

Event Type  Injury  

Event Description

The following event was reported to implantcast gmbh: "components loosened and patient is experiencing recurrent dislocations and instability".

Manufacturer Narrative

After about 7 months in situ an agilon® shoulder prothesis had to be revised, because the metaphyseal component disconnected from the stem.No explants were available for the optical analysis because they were discarded.The communicated details of the used components revealed that the stem and the metaphyseal component were assembled using an incorrect screw length.The screw that was used is 22.5mm in lengths and therefore shorter than the one, that must be used according to the surgical technique (32.5mm) to ensure a correct fixation of the components.With the used components a correct fixation of the stem and the metaphyseal component is not possible.A disconnection of the components is inevitable.In addition, the agilon® xo inverse cap base was used again, after it had disconnected from the metaphyseal component during the first event in (b)(6) 2021.Reusing components is not authorized.And can lead to disconnection of components due to damaged taper connections.The production reports and information material of the components were checked, and no deviations were found.Furthermore, the instruction for use lists "conditions that restrict the patient's ability or willingness to comply with medical instructions, especially during the healing process" and "neuromuscular diseases that can impair the affected limb" as relative contraindications.Additionally, the combination and assembling of the components is described in detail in the surgical technique.The patient suffers from a history of seizures.It is suspected that a previous event, where the inverse cap had detached from the metaphyseal component, was already caused by these seizures.For the event at hand the patient's history of seizures was again mentioned as possible cause for the loosening or detachment of the stem and the metaphyseal component.The underlying cause for the disconnection of the stem and the metaphyseal component is the insufficient connection of the components, caused by the use of a screw, shorter than necessary.

• Brand Name: AGILON®
• Type of Device: STEM CEMENTLESS Ø18/60MM
• 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: 15328026
• MDR Text Key: 298980906
• Report Number: 3012523063-2022-00003
• 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: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 38506018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: AGILON® METAPHYSEAL COMPONENT OMARTHROSIS 140° 40M; AGILON® XO GLENOSPHERE Ø40MM ECCENTRICAL INCL. SCR; AGILON® XO INVERSE CAP BASE Ø40MM M; AGILON® XO RETENTIVE PE-INSERT FOR INVERSE CAP Ø40; AGILON® XO SCREW M6/22.5MM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male