MAUDE Adverse Event Report: ACUMED LLC ARH SLIDE-LOC NECK +1MM; PROSTHESIS, ELBOW, NECK

Model Number 5001-0301N-S

Device Problem Material Separation (1562)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Patient was treated with the slide-loc arh; at three weeks post-op experienced elbow pain.X-ray showed a partial disassociation of the head/neck assembly from the implant stem.Revision surgery was performed; the head was correctly reseated on the neck and then reinserted on the stem, where the laser marks lined up correctly.

Manufacturer Narrative

At this time, the device remains implanted and, thus, is still not returned.During a review of mdrs as part of the market removal of the arh slide-loc product (17-003), it was discovered that during the revision surgery for this case, the laser lines on the head and neck components were not aligned as required by the surgical technique.This is an indicator of poor or inadequate morse taper engagement which can lead to post operative dissociation of the components.The morse taper engagement issue is the result of the operating room staff not performing the engagement activities correctly during the initial surgery.Based on this information, the result and conclusion codes are being changed to indicate that this is a user issue.Additional mdrs associated with this event: 3025141-2015-00133 follow up 1: stem, 3025141-2015-00135 follow up 1: head.

• Brand Name: ARH SLIDE-LOC NECK +1MM
• Type of Device: PROSTHESIS, ELBOW, NECK
• Manufacturer (Section D): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124 9432
• Manufacturer (Section G): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124 9432
• Manufacturer Contact: micki lehman ; 5885 nw cornelius pass road; hillsboro, OR 97124-9432 ; 5036279957
• MDR Report Key: 5060891
• MDR Text Key: 25181369
• Report Number: 3025141-2015-00134
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2021
• Device Model Number: 5001-0301N-S
• Device Catalogue Number: 5001-0301N-S
• Device Lot Number: 327677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2015
• 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