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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2020-00017: neck, 3025141-2020-00018: stem.

Event Description

Patient received a arh slide loc radial head replacement system about 2 year ago.Patient presented with increased pain.X-ray showed the device to be dissociated.It will be revised in a second surgery on (b)(6) 2020.

Manufacturer Narrative

3025141-2020-00017 follow up 1: neck; 3025141-2020-00018 follow up 1: stem.

Event Description

Patient received an arh slide loc roadial head replacement in (b)(6) of 2017.Patient presented with increased pain recently.X-ray showed the device to dissociated.It was revised in a second surgery on "(b)(6) 220" to an arh solutions 2 replacement system.

• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL - HEAD
• Manufacturer (Section D): ACUMEDLLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMEDLLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 9637582
• MDR Text Key: 183717113
• Report Number: 3025141-2020-00016
• 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,Followup
• Report Date: 01/30/2020

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: 01/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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