MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL STEM 7MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number AR-9100-07

Device Problem Component Missing (2306)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Toxicity (2333)

Event Date 01/27/2014

Event Type  Injury  

Event Description

It was reported that a revision surgery was done due to a poor range of motion and increasing pain.The upper third of the metalback glenoid was missing.During surgery a massive "metallose" (metal abrasion) was noticed.The head was removed without any problems but the stem could only be removed after the humerus stem was split.There was only one third of the glenoid inlay existing.The metalback was rubbed off.Surgery was completed successfully, no patient harm reported.

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The devices were requested for evaluation but were not returned therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.As part of the original surgery in europe, there were three (3) other devices that were used that were not cleared for sale in the us.From the event description, the wear of these three (3) devices most likely contributed to the patient's poor range of motion and increasing pain which led to the revision surgery.The potential cause(s) of this event will be communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.

• Brand Name: HUMERAL STEM 7MM
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer Contact: vik bajnath, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 3646461
• MDR Text Key: 4353472
• Report Number: 1220246-2014-00019
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K010124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/03/2014

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: AR-9100-07
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2014
• Initial Date FDA Received: 02/26/2014
• 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
• Treatment: AR-9146-17F, UNIVERS FRACTURE METAL HEAD, LOT UNK.
• Patient Outcome(s): Other