MAUDE Adverse Event Report: DEPUY MITEK UNK LUPINE ANCHOR; MITEK ANCHOR IMPLANTS

Catalog Number UNK LUPINE

Device Problem Insufficient Information (3190)

Patient Problem Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: mitek medical safety department discovered this published white paper detailing a historical event in which some mitek devices were implicated.It cannot be confirmed that this issue had been previously reported to mitek, so an adverse event report is being filed to document the experience described in the article.Additional information was requested from the author but none was provided due to privacy rules.At this point in time, no further action is warranted.However, this file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.Mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi - unavailable.Associated medwatch: 1221934-2017-10225.

Event Description

This report is being filed after the subsequent review of the following literature article: anterior glenoid rim fracture following use of resorbable devices for glenohumeral stabilization.Authors: augusti carlo alberto and ¿et al¿ the orthopaedic journal of sports medicine, 3(6), 2325967115586559.(b)(6).A (b)(6) male that experienced osteolysis around the anchors.

• Brand Name: UNK LUPINE ANCHOR
• Type of Device: MITEK ANCHOR IMPLANTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 6580158
• MDR Text Key: 75604419
• Report Number: 1221934-2017-10224
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK LUPINE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2017
• Date Manufacturer Received: 04/19/2017
• 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): Other
• Patient Age: 19 YR