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

Model Number 5001-0303N-S

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The returned head, neck, and stem components were not assembled together when received at acumed.There were marks in the locking region of the neck that indicated engagement with the stem.The diameter of the locking region did not meet specification but it is possible scratches around the diameter skewed the measurements.There was shearing, deformation, and pits in the locking region of the stem which also indicated engagement with the neck.Additional mdrs associated with this event: 3025141-2018-00088: stem.3025141-2018-00089: head.

Event Description

An arh slide loc radial head replacement was implanted on (b)(6) 2017.The patient was non-compliant and did not follow post op therapies.This resulted in a stiff elbow so the implant was explanted on (b)(6) 2018.

• 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 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: micki lehman ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 8886279957
• MDR Report Key: 7249315
• MDR Text Key: 99298723
• Report Number: 3025141-2018-00090
• 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: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2016
• 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
• Patient Age: 42 YR