MAUDE Adverse Event Report: ACUMED LLC 8MM MORSE TAPER LONG STEM; PROSTHESIS, ELBOW, HEMI-, RADIAL, LONG STEM

Model Number TR-SL08-S

Device Problem Positioning Problem (3009)

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

Event Date 09/26/2018

Event Type  malfunction  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2018-00297: reamer 1, 3025141-2018-00298: reamer 2.

Event Description

A revision with arh long stems occurred.The acumed long stem reamers were used as directed by the technique guide.However, the 8mm long stem would not impact to the proper depth to allow proper elbow function.The surgeon made a ventrical cut down to the radial shaft to remove the implant and then reamed the canal deeper.Surgery was delayed 1.5 hours.

• Brand Name: 8MM MORSE TAPER LONG STEM
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, LONG 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 ; 5032071387
• MDR Report Key: 7977086
• MDR Text Key: 124501422
• Report Number: 3025141-2018-00296
• 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
• Type of Report: Initial
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TR-SL08-S
• Device Catalogue Number: TR-SL08-S
• Device Lot Number: 420842
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2017
• 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 Age: 50 YR