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

Catalog Number UNK ORTHOCORD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Pain (1994)

Event Date 09/13/2012

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 product: 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 is report 2 of 3 for the same event.This report is being filed after the review of the following journal article: lefevre, n., et al (2013), returning to sports after surgical repair of acute proximal hamstring ruptures, knee surgery sports traumatology arthroscopy, vol.21, pages 534-539 (france).Doi: 10.1007/s00167-012-2204-2.The study emphasizes on obtaining a detailed and quantified description of the level of activity before injury and compare this to the level of activity after surgery.The patients evaluated on course of this study: from 2002 to 2011, a total of 34 patients (9 women and 25 men), with a mean age of 39.3 ± 11.4 years old, who underwent a surgical repair of complete or partial proximal hamstring ruptures were included in the study.Inclusion criteria were partial or complete hamstring proximal rupture, acute rupture (treated less than 4 weeks after injury) and surgical treatment.Postoperative clinical assessment was performed at 6 weeks, 3 months, 6 months and 1 year and then every 3 years.The knee was immobilized by a simple splint flexed at 30° to prevent traction on the suture for the first week.Weight-bearing was partial and on crutches.For the next 5 weeks, the splint was replaced by a custom-made hinged knee brace allowing free flexion but limited extension at 30°.Gentle, progressive functional rehabilitation was begun with isometric quadriceps and hamstring exercises, with the knee flexed at 30°.Full weight-bearing and sitting were allowed if there was no pain.On the sixth week, the knee was released, and full weight-bearing was allowed without a cane.Active rehabilitation included progressive dynamic hamstring exercises and closed kinetic chain exercise for the quadriceps.Regular sports activities could be started between weeks 16 and 32.The article describes the following procedure: a surgical repair of an acute proximal hamstring rupture.The devices involved were: orthocord suture (depuy mitek, norwood, massachusetts), mitek gii superanchor, and mitek anchor loop lupine.Complications mentioned in the article: 1 patient had a large hematoma that required emergency evacuation.8.8% of patients had mild discomfort or pain during prolonged sitting.1 patient underwent tendon carding at 71.5 months follow-up due to hamstring tendinopathy following migration of a metallic anchor.

Manufacturer Narrative

Depuy is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy or its employees that the report constitutes an admission that the device, depuy , or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Upon complaint review, it was determined that the event date was inadvertently missed on the initial report; therefore, it has been updated accordingly to reflect the correct information.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.

• Brand Name: UNKNOWN ORTHOCORD
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9245700
• MDR Text Key: 178351698
• Report Number: 1221934-2019-59281
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK ORTHOCORD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention