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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG AS TIBIA OFFSET STEM D20X92 CEMENTLESS KNEE ENDOPROSTHETICS

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AESCULAP AG AS TIBIA OFFSET STEM D20X92 CEMENTLESS KNEE ENDOPROSTHETICS Back to Search Results
Model Number NR180Z
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/24/2020
Event Type  malfunction  
Manufacturer Narrative
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
 
Event Description
It was reported that there was an issue with as tibia offset stem. The reported incident was against catalog item nr180z. It was reported that the stem was packaged in a clear cylinder. The container had significant residue on the inside walls. The stem itself was discolored brown, not standard gold color and had considerable white residue or powder on it. The surgeon was hesitant to use it. This incident did cause a 10 minute delay in surgery. The surgeon used the same stem the allegation was against since there was no back-up in the facility. The patient outcome was good, there were no complications noted. Additional information was not provided nor available / was not available. The adverse event/malfunction is filed under (b)(4).
 
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Brand NameAS TIBIA OFFSET STEM D20X92 CEMENTLESS
Type of DeviceKNEE ENDOPROSTHETICS
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
kerstin rothweiler
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key9824497
MDR Text Key183254735
Report Number9610612-2020-00075
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,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNR180Z
Device Catalogue NumberNR180Z
Device Lot Number52068326
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/09/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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