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

Model Number 5001-0109N-S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2017-00126: neck, 3025141-2017-00127: head.

Event Description

An arh slide-loc implants (head, neck and stem) were explanted for unknown reasons.

Manufacturer Narrative

Three components (head, neck, stem) were returned fully assembled.The laser marks on the three components were aligned properly.There was no gross damage to any of the components.There were some slight scratches present; cause of the scratches is unknown.Additional mdrs associated with this event: 3025141-2017-00126: follow up 1: neck.3025141-2017-00127: follow up 1: head.

• 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
• MDR Report Key: 6645624
• MDR Text Key: 77700818
• Report Number: 3025141-2017-00128
• 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,Followup
• Report Date: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/17/2023
• Device Model Number: 5001-0109N-S
• Device Catalogue Number: 5001-0109N-S
• Device Lot Number: 373593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2016
• 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