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

Model Number 5001-0301N-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: 3025141-2018-00016: head, 3025141-2018-00018: stem.

Event Description

An arh slide-loc radial head replacement system was implanted.At some point post operatively, the head/neck assembly dissociated from the stem.The implants were explanted.

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2018-00016 follow up 1: head, 3025141-2018-00018 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 nw cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: micki lehman ; 5885 nw cornelius pass road; hillsboro, OR 97124 ; 8886279957
• MDR Report Key: 7202192
• MDR Text Key: 97627406
• Report Number: 3025141-2018-00017
• 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: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 5001-0301N-S
• Device Catalogue Number: 5001-0301N-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 63 YR