MAUDE Adverse Event Report: INTEGRUM AB AXOR II

Model Number 1288

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Fall (1848)

Event Date 02/20/2021

Event Type  malfunction  

Event Description

Axor ii dislodged causing the patient to fall.This was reported in an adverse event form as the patient is included in a pilot study ((b)(6)).Axor ii unexpectedly dislodged (b)(6) 2021, resulting in the patient falling.The patient reported hip pain, but no other residual limb symptoms.Plain films of the femur were negative for fracture or implant failure.A previous incident occurred (b)(6) 2021 (see case (b)(4)) and it was decided that the patient would be provided with a loan unit, and that the unit with sn (b)(4) should be returned to iab for investigation.Due to delays in fitting of the loaner unit, the patient continued using the (b)(4).After the incident in question for this case (incident date (b)(6) 2021), the unit was returned to iab for investigation.During investigation, the issue could not be replicated.During service, the axor was cleaned and inspected.The axor passed all attachment tests, including the attachment test with a 13,7mm abutment that replicates a worn abutment.

Event Description

Axor ii dislodged causing the patient to fall.This was reported in an adverse event form as the patient is included in a pilot study (18-25641).Axor ii unexpectedly dislodged (b)(6) 2021, resulting in the patient falling.The patient reported hip pain, but no other residual limb symptoms.Plain films of the femur were negative for fracture or implant failure.A previous incident occurred (b)(6) 2020 (see (b)(4)) and it was decided that the patient would be provided with a loan unit, and that the unit with sn (b)(6) should be returned to iab for investigation.Due to delays in fitting of the loaner unit, the patient continued using the (b)(6).After the incident in question for this case (incident date (b)(6) 2021), the unit was returned to iab for investigation.During investigation, the issue could not be replicated.During service, the axor was cleaned and inspected.The axor passed all attachment tests, including the attachment test with a 13,7mm abutment that replicates a worn abutment.05/21/2021: conclusion from investigation: the reported issue could not be replicated.The device passed all attachment tests, including the attachment test with a 13,7mm abutment that replicates a worn abutment.The device was working as expected.The unit has been returned to the patient together with a feedback report (attached).As described in the protocol violation or incident reporting form provided by the cpo, the incident can be related to patient-related factors (insufficient tightening and/or inadequate cleaning/maintenance).The prosthetic staff working with the clinical study will performing additional patient training, including reinforcement of proper tightening, cleaning and maintenance procedures.

• Brand Name: AXOR II
• Type of Device: AXOR II
• Manufacturer (Section D): INTEGRUM AB; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• MDR Report Key: 11706159
• MDR Text Key: 266920801
• Report Number: 3011386779-2021-00049
• Device Sequence Number: 1
• Product Code: PJY
• UDI-Device Identifier: 07340152100634
• UDI-Public: 07340152100634
• Combination Product (y/n): N
• PMA/PMN Number: P190009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1288
• Device Catalogue Number: 1288
• Device Lot Number: U86792-30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other