MAUDE Adverse Event Report: ACUMED LLC ARH SLIDE-LOC NECK +1MM; PROSTHESIS, ELBOW, HEMI-, RADIAL, NECK

Model Number 5001-0301N-S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The returned slideloc device was returned following explantation.The 1 mm neck was returned attached to the 22 mm head.The neck and head interface was still fully intact.Signs of typical wear caused by implantation and explantation can be seen on the neck.No visible wear is seen on the head.Additional mdrs associated with this event: 3025141-2020-00189: head, 3025141-2020-00191: stem.

Event Description

An arh slideloc radial head replacement implant was implanted in the patient on (b)(6) 2016.The implant was explanted for unknown reasons on (b)(6) 2020.

Event Description

An arh slideloc radial head replacement implant was implanted in the patient on (b)(6) 2016.The implant was explanted for loosening of the head on (b)(6) 2020.

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2020-00189 follow up 1: head.3025141-2020-00191 follow up 1: stem.

• Brand Name: ARH SLIDE-LOC NECK +1MM
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, NECK
• Manufacturer (Section D): ACUMED LLC; 5885 ne cornelius pass road; hillsboro, or
• MDR Report Key: 10324335
• MDR Text Key: 200386199
• Report Number: 3025141-2020-00190
• 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: 07/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2023
• Device Model Number: 5001-0301N-S
• Device Catalogue Number: 5001-0301N-S
• Device Lot Number: 376147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Initial Date Manufacturer Received: 06/26/2020
• Initial Date FDA Received: 07/25/2020
• Supplement Dates Manufacturer Received: 07/26/2020
• Supplement Dates FDA Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR