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

Model Number 5001-0410L-S

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

When placing a anatomic radial head, the surgeon needed a 9mm long stem implant.However, only even number sized implants are available.The surgeon implanted a 10mm stem which sat slightly proud.Three weeks after implantation, it was determined that the joint was overstuffed.During revision surgery, the surgeon attempted to ream the bone again and fully seat the 10mm stem implant.This did not work.The stem was removed and a competitor's product was used.

• Brand Name: ARH SLIDE-LOC, LONG STEM 10MM, LEFT
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
• 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 ; 5036279957
• MDR Report Key: 5140113
• MDR Text Key: 27916305
• Report Number: 3025141-2015-00175
• 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
• Report Date: 09/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2022
• Device Model Number: 5001-0410L-S
• Device Catalogue Number: 5001-0410L-S
• Device Lot Number: 343520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2015
• 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