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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG AS ENDURO TIBIAL COMP.OFFSET CEMENTED T3 KNEE ENDOPROSTHESES

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AESCULAP AG AS ENDURO TIBIAL COMP.OFFSET CEMENTED T3 KNEE ENDOPROSTHESES Back to Search Results
Model Number NB013Z
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/21/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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 the enduro implant packaging. The patient initially underwent a total knee surgery on an unknown date and was implanted with another manufacturer's products. A revision was performed on (b)(6) 2018, and an enduro tibial knee implant was prepared for use to replace the original product. While unpacking the product, it was noted that the inner sterile packing had a large hole in the plastic. Fortunately, the outer packaging was intact and the tibial component implant was able to be used to complete the procedure. It was felt that the inner plastic appeared to have possibly been exposed to high heat. There was no patient harm, intervention, or delay. Additional information has been requested.
 
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Brand NameAS ENDURO TIBIAL COMP.OFFSET CEMENTED T3
Type of DeviceKNEE ENDOPROSTHESES
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
1 a raumantie
helsinki, MO 00350
FI   00350
3145515988
MDR Report Key8249228
MDR Text Key133226400
Report Number9610612-2019-00024
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,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNB013Z
Device Catalogue NumberNB013Z
Device Lot Number52414831
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date02/25/2019
Device Age9 MO
Event Location No Information
Date Manufacturer Received02/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/16/2018
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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