MAUDE Adverse Event Report: ACUMEDLLC; PROSTHESIS, ELBOW, HEMI-, RADIAL - STEM

Device Problems Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2020-00022: head, 3025141-2020-00023: neck.

Event Description

Patient received a arh slide loc radial head replacement system in 2017.X-ray shows that the head/neck construct appears to be dissociated from the stem.Revision surgery has not been scheduled to date.

Event Description

Patient received a arh slide loc radial head replacement system in 2017.X-ray shows that the head/neck construct appeared to be dissociated from the stem.Revision surgery was performed on (b)(6) 2020.

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2020-00022 follow up 1: head, and 3025141-2020-00023 follow up 1: neck.

• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL - STEM
• Manufacturer (Section D): ACUMEDLLC; 5885 ne cornelius pass road; hillsboro OR 97124
• MDR Report Key: 9637596
• MDR Text Key: 183718147
• Report Number: 3025141-2020-00024
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• 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: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention