MAUDE Adverse Event Report: ACUMED LLC; PROSTHESIS, ELBOW, HEMI-, RADIAL - NECK

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this event.3025141-2021-00035: head.3025141-2021-00037: stem.

Event Description

A arh slideloc radial head replacement system has been implanted about 5 years ago.At some point post op, the neck may have disengaged partially.The implant may need to be removed.

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2021-00035: follow up 1: head.3025141-2021-00037: follow up 1: stem.

Event Description

On (b)(6) 2021, the arh slideloc radial head replacement implant system was explanted from the patient's elbow and replaced with new arh slideloc implants.Original implants not returned to acumed.

• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL - NECK
• Manufacturer (Section D): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• MDR Report Key: 11733213
• MDR Text Key: 249959416
• Report Number: 3025141-2021-00036
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: K131845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention