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

Model Number 5001-0109N-S

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The parts were examined visually both with and without magnification.The laser marks between the head and neck were aligned.There were burnish marks on the bottom of the neck and stem platform.There were marks in the locking region of the neck and stem that indicated engagement between the components.The diameters that define the locking regions on the neck and stem appears to be within manufacturing specification.Additional mdrs associated with this event: 3025141-2017-00309: head; 3025141-2017-00310: neck.

Event Description

An arh slide-loc radial head replacement system was implanted on (b)(6) 2016.At some point post operatively, the head/neck assembly dissociated from the stem.The product was explanted on (b)(6) 2017.

• 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
• 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: 7098337
• MDR Text Key: 94193416
• Report Number: 3025141-2017-00311
• 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
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/28/2023
• Device Model Number: 5001-0109N-S
• Device Catalogue Number: 5001-0109N-S
• Device Lot Number: 368412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2016
• 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