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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED LLC; PROSTHESIS, ELBOW, HEMI-, RADIAL
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ACUMED LLC; PROSTHESIS, ELBOW, HEMI-, RADIAL Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Capsular Contracture (1761)
Event Type  Injury  
Manufacturer Narrative
Additional mdrs associated with this article: 3025141-2019-00160: case 1, 3025141-2019-00161: case 2, 3025141-2019-00162: case 3, 3025141-2019-00163: case 4, 3025141-2019-00164: case 5, 3025141-2019-00165: case 6, 3025141-2019-00166: case 7.
 
Event Description
Article: the clinical implications of heterotropic ossification in patients treated with radial head replacement for trauma: a case series and review of literature.Bowman, seth h., barfield, william r., slone, harris s., shealy, gerald j., walton, zeke j.Journal of orthopaedics 13 (2016) 272-277.Case 8: revision surgery performed for capsular contracture only.
 
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Type of Device
PROSTHESIS, ELBOW, HEMI-, RADIAL
Manufacturer (Section D)
ACUMED LLC
5885 ne cornelius pass road
hillsboro OR 97124
Manufacturer (Section G)
ACUMED LLC
5885 ne cornelius pass road
hillsboro OR 97124
Manufacturer Contact
micki anderson
5885 ne cornelius pass road
hillsboro, OR 97124
8886279957
MDR Report Key8443132
MDR Text Key139535782
Report Number3025141-2019-00167
Device Sequence Number0
Product Code KWI
Reporter Country CodeUS
PMA/PMN Number
K131845
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2019
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received03/01/2019
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 Number1
Patient Outcome(s) Required Intervention;
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