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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AAP BIOMATERIALS GMBH CARDINAL HEALTH ARTHROPLASTY BONE CEMENT
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AAP BIOMATERIALS GMBH CARDINAL HEALTH ARTHROPLASTY BONE CEMENT Back to Search Results
Model Number CMT-40-1
Medical Device Problem Codes Inadequate or Insufficient Training (1643); Device Handling Problem (3265)
Health Effect - Clinical Codes Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event 11/28/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device not available for evaluation.
 
Event or Problem Description
Mixinng time: 90 seconds; bone cement implantation after 2:38 minutes; tibia plate implantation after 3:30 minutes; curing time 15 minutes (longer than expected); delay in surgery (some minutes).
 
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Brand Name
CARDINAL HEALTH ARTHROPLASTY BONE CEMENT
Common Device Name
CARDINAL HEALTH ARTHROPLASTY BONE CEMENT
Manufacturer (Section D)
AAP BIOMATERIALS GMBH
lagerstrasse 11-15
dieburg, 64807
GM  64807
MDR Report Key6325161
Report Number9615014-2017-00017
Device Sequence Number19102732
Product Code LOD
UDI-Device Identifier10885380066511
UDI-Public10885380066511
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K123225
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source distributor,foreign
Initial Reporter Occupation Other
Remedial Action Notification
Type of Report Initial
Report Date (Section B) 02/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Physician
Device Expiration Date06/30/2017
Device Model NumberCMT-40-1
Device Catalogue NumberCMT-40-1
Device Lot Number15FA52050
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/16/2017
Initial Report FDA Received Date02/13/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
(B)(4) CARTRIDGE MIXING SYSTEM
Outcome Attributed to Adverse Event Hospitalization;
Patient Age50 YR
Patient Weight70
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