MAUDE Adverse Event Report: ACUMED LLC ARH SLIDE-LOC¿ STANDARD STEM 9MM; PROSTHESIS, ELBOW, HEMI-, RADIAL, STEM

Model Number 5001-0109N-S

Device Problem Disassembly (1168)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2017-00051: head, 3025141-2017-00052: neck.

Event Description

An anatomical radial head was implanted.At some point post operatively, the head/neck component dissociated from the stem.The implants were explanted.

• Brand Name: ARH SLIDE-LOC¿ STANDARD STEM 9MM
• 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
• MDR Report Key: 6471832
• MDR Text Key: 72107593
• Report Number: 3025141-2017-00050
• 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: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/07/2023
• Device Model Number: 5001-0109N-S
• Device Catalogue Number: 5001-0109N-S
• Device Lot Number: 368480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2016
• 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