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

Model Number 5001-0301N-S

Device Problems Nonstandard Device (1420); Appropriate Term/Code Not Available (3191); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

The neck was visually examined.The laser marks between the head and neck were aligned.The head and neck was not separated.There was no damage to the locking region of the neck.Additional mdrs associated with this event: 3025141-2019-00142: head; 3025141-2019-00144: stem.

Event Description

An implanted arh slide-loc radial replacement system was removed in revision surgery.The head and the stem were loose and easily removed.

• 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 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 8433612
• MDR Text Key: 139236966
• Report Number: 3025141-2019-00143
• Device Sequence Number: 0
• Product Code: KWI
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2024
• Device Model Number: 5001-0301N-S
• Device Catalogue Number: 5001-0301N-S
• Device Lot Number: 401367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Date Manufacturer Received: 02/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2017
• 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
• Patient Age: 46 YR
• Patient Weight: 71