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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED LLC; PROSTHESIS, ELBOW, HEMI-, RADIAL: HEAD
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ACUMED LLC; PROSTHESIS, ELBOW, HEMI-, RADIAL: HEAD Back to Search Results
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: 3025141-2020-00198: neck, 3025141-2020-00199: stem.
 
Event Description
An arh slideloc radial head replacement system was implanted in a patient.The implant was removed for unknown reasons.
 
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.
 
Manufacturer Narrative
H3: the laser marks between the head and neck were aligned.Additional mdrs associated with this event: 3025141-2020-00198 follow up 1: neck, and 3025141-2020-00199 follow up 1: stem.
 
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Type of Device
PROSTHESIS, ELBOW, HEMI-, RADIAL: HEAD
Manufacturer (Section D)
ACUMED LLC
5885 ne cornelius pass road
hillsboro, or
MDR Report Key10431265
MDR Text Key203686735
Report Number3025141-2020-00197
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 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
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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