MAUDE Adverse Event Report: ACUMED LLC ARH SLIDE-LOC¿ HEAD 24MM, RIGHT; PROSTHESIS, ELBOW, HEAD

Model Number 5001-0224R-S

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The head was examined visually with a microscope and with the naked eye.The head showed no signs of damage and was seated correctly on the neck (laser marks aligned).Additional mdr's associated with this event: 3025141-2016-00160: stem; 3025141-2016-00161: neck.

Event Description

Arh slide-loc products were implanted on (b)(6) 2016.At some point post operatively, the head/neck assembly disassociated from the stem.The head and neck parts were explanted on (b)(6) 2016; the stem remains implanted.

• Brand Name: ARH SLIDE-LOC¿ HEAD 24MM, RIGHT
• Type of Device: PROSTHESIS, ELBOW, HEAD
• 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: 5866943
• MDR Text Key: 51814619
• Report Number: 3025141-2016-00159
• 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: Initial
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2022
• Device Model Number: 5001-0224R-S
• Device Catalogue Number: 5001-0224R-S
• Device Lot Number: 318852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2015
• 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