MAUDE Adverse Event Report: ACUMED LLC ARH SLIDE-LOC¿ STANDARD STEM 10MM; PROSTHESIS, ELBOW, HEMI-, RADIAL, STEM

Model Number 5001-0110N-S

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2017-00249: neck, 3025141-2017-00251: head.

Event Description

A surgeon implanted an arh slide loc radial head replacement system on (b)(6) 2017.On (b)(6) 2017, the implants were removed for unknown reasons.

• Brand Name: ARH SLIDE-LOC¿ STANDARD STEM 10MM
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, STEM
• Manufacturer (Section D): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124 9432
• Manufacturer (Section G): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124 9432
• Manufacturer Contact: micki lehman ; 5885 nw cornelius pass road; hillsboro, OR 97124-9432 ; 8886279957
• MDR Report Key: 6938309
• MDR Text Key: 90295925
• Report Number: 3025141-2017-00250
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/04/2023
• Device Model Number: 5001-0110N-S
• Device Catalogue Number: 5001-0110N-S
• Device Lot Number: 381003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention