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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED LLC 26.0MM HEAD, RIGHT; PROSTHESIS, ELBOW, HEMI-, RADIAL: HEAD
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ACUMED LLC 26.0MM HEAD, RIGHT; PROSTHESIS, ELBOW, HEMI-, RADIAL: HEAD Back to Search Results
Model Number TR-H260R-S
Device Problems Moisture Damage (1405); Packaging Problem (3007)
Patient Problem Insufficient Information (4580)
Event Date 09/25/2021
Event Type  malfunction  
Manufacturer Narrative
Box and inner packaging were examined and found to be water damaged and moldy upon physical examination.Packaging was disposed of appropriately and the implant was cleaned and filed with complaint product.
 
Event Description
At an arh case (anatomic radial head replacement), the sales rep presented the sterile packed implants for the surgery.The implant's packaging was water damaged and moldy and the sterility of the implants was questionable.The surgery was ended without placing the implants.A second surgery was performed on the next day with appropriately packaged implants with no issue.
 
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Brand Name
26.0MM HEAD, RIGHT
Type of Device
PROSTHESIS, ELBOW, HEMI-, RADIAL: HEAD
Manufacturer (Section D)
ACUMED LLC
5885 ne cornelius pass road
hillsboro OR 97124
MDR Report Key12647911
MDR Text Key279604069
Report Number3025141-2021-00109
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 health professional
Type of Report Initial
Report Date 09/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberTR-H260R-S
Device Catalogue NumberTR-H260R-S
Device Lot Number464113
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2021
Date Manufacturer Received09/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/09/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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