MAUDE Adverse Event Report: ACUMED LLC ARH SOLUTIONS 2 HEAD 24MM, RIGHT; PROSTHESIS, ELBOW, HEMI-, RADIAL, HEAD

Model Number 5001-0524R-S

Device Problems Loose or Intermittent Connection (1371); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Insufficient Information (4580)

Event Date 08/19/2020

Event Type  malfunction  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2020-00225: stem 1, 3025141-2020-00226: head 1, 3025141-2020-00227: stem 2.

Event Description

While implanting an arh radial head replacement system in the patient, the initial stem was found to be loose in the bone canal so the stem was upsized however the head could not be removed from the stem so a new head was used.That stem was found to be too large so it was removed and a long stem was used, along with another new head.These actions caused a one hour long delay in surgery.

• Brand Name: ARH SOLUTIONS 2 HEAD 24MM, 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: 10542979
• MDR Text Key: 208324931
• Report Number: 3025141-2020-00228
• 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: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5001-0524R-S
• Device Catalogue Number: 5001-0524R-S
• Device Lot Number: 475520
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2020
• 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 Age: 67 YR