MAUDE Adverse Event Report: ACUMED LLC ARH SLIDE-LOC¿ STANDARD STEM 9MM; PROSTHESIS, ELBOW, HEMI-, RADIAL, STEM

Model Number 5001-0109N-S

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2017-00215: head; 3025141-2017-00216: neck.

Event Description

An arh slide-loc radial head replacement product was implanted.On (b)(6) 2017, the implant was explanted for unknown reasons.

• Brand Name: ARH SLIDE-LOC¿ STANDARD STEM 9MM
• 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: 6909797
• MDR Text Key: 87987863
• Report Number: 3025141-2017-00217
• 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: Other
• Type of Report: Initial
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/30/2022
• Device Model Number: 5001-0109N-S
• Device Catalogue Number: 5001-0109N-S
• Device Lot Number: 371684
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2016
• 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