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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG METHA SHORT HIP STEM CAP SIZE 1 IMPLANTS METHA

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AESCULAP AG METHA SHORT HIP STEM CAP SIZE 1 IMPLANTS METHA Back to Search Results
Model Number NC081T
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Joint Disorder (2373)
Event Date 02/12/2020
Event Type  Injury  
Manufacturer Narrative
Due to a lack of components, an investigation could not take place. The failure is most probably patient related. Due to the fact that we did not receive the product for investigation, a clear conclusion can not be drawn. Based on the information, it is most likely that an osteolysis led to the stem (and cup) loosening after the mentioned in-vivo time. The following information can be found in the corresponding ifu: "insufficient quality of the bone or osseous deformities, or disorders in the implant fixation area which could impair the stability of the fixation of the joint replacement primarly or over time. " the device history records have been checked for the available lot numbers and found to be according to the specification, valid at the time of production. No further complaints registered against the same lot number (51645754) of the metal stem.
 
Event Description
It was reported that there was an issue with metha short hip stem. According to the complaint "descripition" it was reported that the stem became loose after 5 years and 7 months. Revision surgery: (b)(6). Revision surgery: (b)(6). A revision surgery was necessary. Additional information was not provided nor available. The adverse event is filed under aag reference (b)(4).
 
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Brand NameMETHA SHORT HIP STEM CAP SIZE 1
Type of DeviceIMPLANTS METHA
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 Key9968419
MDR Text Key189453313
Report Number9610612-2020-00140
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 04/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/01/2020
Device Model NumberNC081T
Device Catalogue NumberNC081T
Device Lot Number51645754
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 Received02/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/10/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/16/2020 Patient Sequence Number: 1
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