MAUDE Adverse Event Report: DEPUY MITEK LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DS; MITEK ANCHOR IMPLANTS

Catalog Number 210712

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Osteolysis (2377)

Event Date 08/15/2015

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Associated medwatch for second implant: 1221934-2016-10096.(b)(4).The lot expiration is currently unavailable.

Event Description

A report was received from dr.(b)(6) regarding the 2 defective lupine br ds suture anchor w/ orthocord that was used to his patient last (b)(6) 2015.The patient started to experience soreness 5 months after the procedure.On the (b)(6) month, patient sought another shoulder surgeon (dr.(b)(6)) for second opinion.Several imaging studies and blood work-ups was done.Mri and xray revealed lysis of the greater tuberosity of the humerus.While ultrasound guided biopsy showed growth of pseudomonas aeruginosa.Additional information was received via email from the affiliate on (b)(6) 2016.Still checking if the lot numbers can be traced.The anchors were removed, 3rd or 4th week of (b)(6).The anchors were already disposed as those were infectious as per surgeon.

Manufacturer Narrative

The complaint device is not available for a physical evaluation and no further information is available to determine a root cause for this failure.It cannot be concluded that mitek product was the cause of the infection in patient.A batch record review has been conducted and the results indicate that this batch of product was processed without any incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.A complaint history of this product family revealed no other infection complaints in the last 3 years.This seems to be an isolated incident and it is a possibility that other factors may have contributed to the event.At this point in time, no further action is warranted.However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed.Depuy 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.(b)(4).

• Brand Name: LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DS
• Type of Device: MITEK ANCHOR IMPLANTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808210
• MDR Report Key: 5509646
• MDR Text Key: 40632717
• Report Number: 1221934-2016-10095
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK070925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: 210712
• Device Lot Number: 3662436
• 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: 02/17/2016
• Date Manufacturer Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2012
• 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): Required Intervention