MAUDE Adverse Event Report: ACUMED LLC ARH SLIDE-LOC¿ LONG STEM 6MM, RIGHT; PROSTHESIS, ELBOW, HEMI-, RADIAL, STEM

Model Number 5001-0406R-S

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  Injury  

Manufacturer Narrative

Mdr filed late due to mix up in aware date during complaint investigation.Additional mdrs associated with this event: 3025141-2017-00202: head; 3025141-2017-00203: neck.

Event Description

Arh slide-loc radial head replacement implants were explanted to prevent future dissociation of the head/neck assembly from the stem.

• Brand Name: ARH SLIDE-LOC¿ LONG STEM 6MM, RIGHT
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, STEM
• Manufacturer (Section D): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124 9432
• Manufacturer (Section G): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124 9432
• Manufacturer Contact: micki lehman ; 5885 nw cornelius pass road; hillsboro, OR 97124-9432 ; 8886279957
• MDR Report Key: 6852011
• MDR Text Key: 85369404
• Report Number: 3025141-2017-00204
• 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: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/22/2022
• Device Model Number: 5001-0406R-S
• Device Catalogue Number: 5001-0406R-S
• Device Lot Number: 367585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2016
• 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: 68 YR