MAUDE Adverse Event Report: DEPUY MITEK LLC US UNK - IMPLANTS; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number UNK - IMPLANTS

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant medical products: unknown.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This report is being filed after the review of the following journal article: bouguennec, n., et al (2019), the migratory cortical button: a rare case of hypersensitivity to titanium after an anterior cruciate ligament reconstruction, knee surgery and related research, vol.31(2), pages 132-136 (france).The study emphasizes on a (b)(6)-year-old man who underwent anterior cruciate ligament (acl) reconstruction using a hamstring autograft with femoral cortical suspension device on the femoral side ad a bioabsorbable screw on the tibial side.The patient visited a clinic due to chronic instability of the left knee and complained of frequent instability of the knee in daily activities.The patient sustained a knee injury while practicing judo 2 months before the presentation.Magnetic resonance imaging (mri) showed a rupture of the acl without any meniscal lesion.The patient had severe atopic dermatitis with severe general eczema, but allergy tests did not reveal any allergy to metal.Acl reconstruction was performed 3 months after the trauma.Nine months after the surgery, the patient came to the clinic due to pain at the aperture of the tibial tunnel.A cyst around the tibial screw was observed and the screw was removed.On the 9-month postoperative mri, the femoral cortical button was observed to be no longer fixed against the femoral cortex.Three years after the surgery, the patient called the clinic because the cortical button had protruded from the skin.The patient was seen at the clinic with the cortical button in the hand.The patient had removed the cortical button from the thigh.The case report describes the following procedure: underwent anterior cruciate ligament (acl) reconstruction using a hamstring autograft with femoral cortical suspension device on the femoral side ad a bioabsorbable screw on the tibial side.The devices involved were: rigidloop 30-mm fixed loop implant (depuy synthes mitek, raynham, ma, usa) cortical button on the femoral side; bioabsorbable ligafix scresw 9/30 on the tibial side.Complication mentioned in the article: the cortical button was no longer fixed against the femoral cortex and had protruded from the skin.

• Brand Name: UNK - IMPLANTS
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 9278460
• MDR Text Key: 184843721
• Report Number: 1221934-2019-59428
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - IMPLANTS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/05/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR