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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG AS TIBIA OFFSET STEM D20X92 CEMENTLESS STEMS (IMPLANTS) COLUMBUS

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AESCULAP AG AS TIBIA OFFSET STEM D20X92 CEMENTLESS STEMS (IMPLANTS) COLUMBUS Back to Search Results
Model Number NR180Z
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/14/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). There is no product on hand, therefore an investigation is not possible. This case was discussed with the quality coordinator and it was determined that during the manufacturing process it is not possible for such a defect to occur. Additionally, there is 100 % final inspection, and if the defect was present it would have been observed. The origins of this foreign contaminant is unknown. The root cause of the event was unable to be determined, since the defect is not manufacturing-related. A batch history review was performed for the batch and there was no related complaints for the this failure against batch number 51858838.
 
Event Description
It was reported that upon removal from the sterile package that there were "black sand-like or powder-like" debris near threads and within sterile container. The implant was washed with sterile saline which contained antibiotics to remove debris. The device was implanted during surgery. There was no reported harm to patient and a less than 5 minute delay in surgery.
 
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Brand NameAS TIBIA OFFSET STEM D20X92 CEMENTLESS
Type of DeviceSTEMS (IMPLANTS) COLUMBUS
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer (Section G)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer Contact
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key7895780
MDR Text Key120960662
Report Number9610612-2018-00412
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101815
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 09/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/01/2022
Device Model NumberNR180Z
Device Catalogue NumberNR180Z
Device Lot Number51858838
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date08/28/2018
Device Age6 YR
Event Location No Information
Date Manufacturer Received08/23/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/01/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/20/2018 Patient Sequence Number: 1
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