MAUDE Adverse Event Report: ACUMED LLC ARH SOLUTIONS HEAD 26MM, RIGHT; PROSTHESIS, ELBOW, HEMI-, RADIAL, HEAD

Model Number 5001-0226R-S

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2020-00236: stem, 3025141-2020-00238: neck.

Event Description

An arh slideloc radial head replacement system was implanted in the patient on (b)(6) 2016.Post op, x-rays indicated the head had dissociated from the stem.The hardware was removed in a revision surgery on (b)(6) 2020 and replaced with an arh solutions 2 system.

• Brand Name: ARH SOLUTIONS HEAD 26MM, RIGHT
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, HEAD
• Manufacturer (Section D): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 8886279957
• MDR Report Key: 10662642
• MDR Text Key: 211032168
• Report Number: 3025141-2020-00237
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2022
• Device Model Number: 5001-0226R-S
• Device Catalogue Number: 5001-0226R-S
• Device Lot Number: 359421
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2015
• 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
• Patient Age: 62 YR