MAUDE Adverse Event Report: ACUMED LLC ARH SLIDE-LOC¿ HEAD 24MM, LEFT; PROSTHESIS, ELBOW, HEMI-, RADIAL, HEAD

Model Number 5001-0224L-S

Device Problem Detachment Of Device Component (1104)

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

Event Type  malfunction  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2017-00063: neck, 3025141-2017-00064: stem.

Event Description

An anatomical radial head was implanted.At some point post operatively, the head/neck component dissociated from the stem.The implants have not been explanted.

• Brand Name: ARH SLIDE-LOC¿ HEAD 24MM, LEFT
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, HEAD
• 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
• MDR Report Key: 6493837
• MDR Text Key: 73025677
• Report Number: 3025141-2017-00062
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K1318491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/29/2023
• Device Model Number: 5001-0224L-S
• Device Catalogue Number: 5001-0224L-S
• Device Lot Number: 375394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2016
• 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