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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED LLC ARH SLIDE-LOC STANDARD STEM 8MM; PROSTHESIS, ELBOW, HEMI-, RADIAL: STEM
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ACUMED LLC ARH SLIDE-LOC STANDARD STEM 8MM; PROSTHESIS, ELBOW, HEMI-, RADIAL: STEM Back to Search Results
Model Number 5001-0108N-S
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
Additional mdrs associated with this event: 3025141-2020-00197: head, 3025141-2020-00198: neck.
 
Event Description
An arh slideloc radial head replacement system was implanted in a patient.The implant was removed for unknown reasons.
 
Manufacturer Narrative
H3: there was deformation in the locking region of the stem.Some deformation expected when stem and neck is locked.A lot damage noted on the stem platform, possibly caused during explant procedure.Additional mdrs associated with this event: 3025141-2020-00197 follow up 1: head, and 3025141-2020-00198 follow up 1: neck.
 
Event Description
An arh slideloc radial head replacement system wsa implanted in a patient.The implant was removed per the patient request, as she had been in a car accident and the implant was causing stiffness and could hardly be moved.It was explanted on (b)(6) 2020.
 
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Brand Name
ARH SLIDE-LOC STANDARD STEM 8MM
Type of Device
PROSTHESIS, ELBOW, HEMI-, RADIAL: STEM
Manufacturer (Section D)
ACUMED LLC
5885 ne cornelius pass road
hillsboro, or
MDR Report Key10431273
MDR Text Key203683006
Report Number3025141-2020-00199
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,study
Type of Report Initial,Followup
Report Date 08/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number5001-0108N-S
Device Catalogue Number5001-0108N-S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2020
Date Manufacturer Received08/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age35 YR
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