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

Model Number 5001-0224L-S

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

A physical examination of the arh slide-loc head 24mm, left was performed, including microscopic examination.The thread portion of the returned part met specifications.Additional mdrs associated with this event: 3025141-2016-00097: arh slide-loc neck +1mm.3025141-2016-00098: arh slide-loc standard stem 9mm.

Event Description

An arh slide-loc radial head was implanted.The head/neck assembly portion of the implant became disassociated from the stem portion post operatively.The implants were explanted.

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2016-00097 follow up 1: neck, 3025141-2016-00098 follow up 1: stem.

• Brand Name: ARH SLIDE-LOC¿ HEAD 24MM, LEFT
• 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: 5573086
• MDR Text Key: 42507043
• Report Number: 3025141-2016-00099
• 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,Followup
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• 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: 5001-0224L-S
• Device Catalogue Number: 5001-0224L-S
• Device Lot Number: 340988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2014
• 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
• Patient Weight: 56