MAUDE Adverse Event Report: ACUMED LLC ARH SLIDE LOC STEM; PROSTHESIS, ELBOW, HEMI-, RADIAL, HEAD

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Associated mdrs for this event: 3025141-2016-00204: head, 3025141-2016-00205: neck.

Event Description

Following implantation of the arh slideloc radial head replacement, the head/neck assembly disassociated from the stem as some point post-operatively.The implants were explanted from the patient.

• Brand Name: ARH SLIDE LOC STEM
• 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 ; 5036279957
• MDR Report Key: 6077463
• MDR Text Key: 59118965
• Report Number: 3025141-2016-00206
• 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: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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