MAUDE Adverse Event Report: ACUMED LLC ARH SLIDE-LOC¿ STANDARD STEM 10MM; PROSTHESIS, ELBOW, HEMI-, RADIAL, STEM

Model Number 5001-0110N-S

Device Problems Nonstandard Device (1420); Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2018-00256: head; 3025141-2018-00256: neck.

Event Description

An arh slide-loc radial head replacement system was implanted in the patient in (b)(6) 2016.At some point post op, the head/neck dissociated from the stem.On (b)(6) 2018, the system was explanted.

• Brand Name: ARH SLIDE-LOC¿ STANDARD STEM 10MM
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, STEM
• 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: 7698719
• MDR Text Key: 114328804
• Report Number: 3025141-2018-00255
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2022
• Device Model Number: 5001-0110N-S
• Device Catalogue Number: 5001-0110N-S
• Device Lot Number: 371855
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2016
• 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