MAUDE Adverse Event Report: ACUMED LLC ARH SLIDE-LOC¿ NECK +3MM; PROSTHESIS, ELBOW, HEMI-, RADIAL: NECK

Model Number 5001-0303N-S

Device Problem Material Separation (1562)

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

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2020-00120: head, 3025141-2020-00122: stem.

Event Description

An arh slide-loc radial head replacement system was implanted in the patient in 2017.At some point post op, the head/neck dissociated from the stem.The system was explanted on (b)(6) 2020.

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2020-00120 follow up 1: head.3025141-2020-00122 follow up 1: stem.

• Brand Name: ARH SLIDE-LOC¿ NECK +3MM
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL: NECK
• Manufacturer (Section D): ACUMED LLC; 5885 ne cornelius pass road; hillsboro, or
• MDR Report Key: 10063276
• MDR Text Key: 191179083
• Report Number: 3025141-2020-00121
• 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: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2023
• Device Model Number: 5001-0303N-S
• Device Catalogue Number: 5001-0303N-S
• Device Lot Number: 375780
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 73