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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED LLC ARH SOLUTIONS HEAD 22MM, RIGHT; PROSTHESIS, ELBOW, HEMI-, RADIAL, HEAD
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ACUMED LLC ARH SOLUTIONS HEAD 22MM, RIGHT; PROSTHESIS, ELBOW, HEMI-, RADIAL, HEAD Back to Search Results
Model Number 5001-0222R-S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
The returned slideloc device was returned following explantation.The 1 mm neck was returned attached to the 22 mm head.The neck and head interface was still fully intact.Signs of typical wear caused by implantation and explantation can be seen on the neck.No visible wear is seen on the head.Additional mdrs associated with this event: 3025141-2020-00190: neck, 3025141-2020-00191: stem.
 
Event Description
An arh slideloc radial head replacement implant was implanted in the patient on (b)(6) 2016.The implant was explanted for unknown reasons on (b)(6) 2020.
 
Manufacturer Narrative
Additional mdrs associated with this event: 3025141-2020-00190 follow up 1: neck, and 3025141-2020-00191 follow up 1: stem.
 
Event Description
An arh slideloc radial head replacement implant was implanted in the patient on (b)(6) 2016.The impant was explanted for loosening of the head on (b)(6) 2020.
 
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Brand Name
ARH SOLUTIONS HEAD 22MM, RIGHT
Type of Device
PROSTHESIS, ELBOW, HEMI-, RADIAL, HEAD
Manufacturer (Section D)
ACUMED LLC
5885 ne cornelius pass road
hillsboro, or
MDR Report Key10324332
MDR Text Key200386163
Report Number3025141-2020-00189
Device Sequence Number1
Product Code KWI
Combination Product (y/n)N
PMA/PMN Number
K131845
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 07/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/28/2022
Device Model Number5001-0222R-S
Device Catalogue Number5001-0222R-S
Device Lot Number340993
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2020
Date Manufacturer Received07/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age69 YR
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