MAUDE Adverse Event Report: INTEGRUM AB OPRA IMPLANT SYSTEM; FIXTURE

Device Problem Loss of Osseointegration (2408)

Patient Problem Implant Pain (4561)

Event Date 03/15/2023

Event Type  Injury  

Manufacturer Narrative

The most probable root cause is deep infection with loosening of the fixture.

Event Description

Fixture extraction surgery for a femur patient due to infection and loosening.Pain when loading was reported as a clinical sign in addition to the infection.Fixture removal took place on (b)(6) 2023.

• Brand Name: OPRA IMPLANT SYSTEM
• Type of Device: FIXTURE
• Manufacturer (Section D): INTEGRUM AB; mölndal, ; SW
• Manufacturer (Section G): INTEGRUM AB; mölndal, ; SW
• Manufacturer Contact: matilda foung ; mölndal, ; SW
• MDR Report Key: 16831616
• MDR Text Key: 314172292
• Report Number: 3011386779-2023-00112
• Device Sequence Number: 1
• Product Code: PJY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 61 KG