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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS METHA NECK 12/14 135°/0°; HIP ENDOPROSTHETICS
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AESCULAP IMPLANT SYSTEMS METHA NECK 12/14 135°/0°; HIP ENDOPROSTHETICS Back to Search Results
Model Number NC087T
Device Problems Fracture (1260); Material Integrity Problem (2978)
Patient Problems Non-union Bone Fracture (2369); Patient Problem/Medical Problem (2688)
Event Date 01/13/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Manufacturing site evaluation: according to the provided information, it came to a breakage of the metha neck adapter post operatively after the patient spins during standing.The breakage occurred (b)(6) 2018.The primary surgery date was not submitted.Therefore implantation period is unknown.Product was not received for the investigation.The device history records have been checked and found to be according to the specification, valid at the time of production.There is no indication of a material failure or a manufacturing defect.The failure is most probably not product related.Due to the fact that the product was not received for investigation.A clear conclusion can not be drawn.The product is not on the market since 2017.A capa is not necessary.
 
Event Description
Country of complaint: (b)(6).Spontaneous fracture of the prosthesis when turning from a standing position.
 
Manufacturer Narrative
Correction: submission submitted in error.This is not usa product.No follow up information is required.
 
Manufacturer Narrative
Additional information : event probelm: components in use listed as concomitant devices are: nc088k / metha neck 12/14 135°/0°.Nc083t / metha short hip stem, cap size 3.Concomitant medical products: nc088k / metha neck 12/14 135°/0°.Nc083t / metha short hip stem cap size 3.
 
Event Description
Components in use listed as concomitant devices are: nc088k / metha neck 12/14 135°/0°.Nc083t / metha short hip stem, cap size 3.
 
Manufacturer Narrative
Additional information: event problem: components in use listed as concomitant devices are: nc087t / metha neck 12/14 135°/7.5°l ante-r retro.Nc083t / metha short hip stem cap size 3.Ae-qas-compet-imp / collect.No.Qas implants from competitors.Ae-qas-compet-imp / collect.No.Qas implants from competitors.Ae-qas-compet-imp / collect.No.Qas implants from competitors.Ae-qas-compet-imp / collect.No.Qas implants from competitors.Concomitant medical products: nc087t / metha neck 12/14 135°/7.5°l ante-r retro.Nc083t / metha short hip stem cap size 3.Ae-qas-compet-imp / collect.No.Qas implants from competitors.Ae-qas-compet-imp / collect.No.Qas implants from competitors.Ae-qas-compet-imp / collect.No.Qas implants from competitors.Ae-qas-compet-imp / collect.No.Qas implants from competitors.
 
Event Description
Components in use listed as concomitant devices are: nc087t / metha neck 12/14 135°/7.5°l ante-r retro.Nc083t / metha short hip stem ¿cap size 3.Ae-qas-compet-imp / collect.No.Qas implants from competitors.Ae-qas-compet-imp / collect.No.Qas implants from competitors.Ae-qas-compet-imp / collect.No.Qas implants from competitors.Ae-qas-compet-imp / collect.No.Qas implants from competitors.
 
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Brand Name
METHA NECK 12/14 135°/0°
Type of Device
HIP ENDOPROSTHETICS
Manufacturer (Section D)
AESCULAP IMPLANT SYSTEMS
po box 40
tuttlingen, 78501
GM  78501
MDR Report Key7301113
MDR Text Key101258236
Report Number9610612-2018-00030
Device Sequence Number1
Product Code LWJ
Combination Product (y/n)N
PMA/PMN Number
K071916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 06/25/2018
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
Device Operator Health Professional
Device Expiration Date01/31/2014
Device Model NumberNC087T
Device Catalogue NumberNC087T
Device Lot Number51254974
Was Device Available for Evaluation? No
Distributor Facility Aware Date01/31/2018
Device Age6 YR
Initial Date Manufacturer Received 01/30/2018
Initial Date FDA Received02/27/2018
Supplement Dates Manufacturer Received04/27/2018
04/27/2018
06/20/2018
Supplement Dates FDA Received04/27/2018
06/18/2018
06/25/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
AE-QAS-COMPET-IMP / COLLECT.NO.QAS IMPLANTS FROM C; AE-QAS-COMPET-IMP / COLLECT.NO.QAS IMPLANTS FROM C; AE-QAS-COMPET-IMP / COLLECT.NO.QAS IMPLANTS FROM C; AE-QAS-COMPET-IMP / COLLECT.NO.QAS IMPLANTS FROM C; NC083T / METHA SHORT HIP STEM, CAP SIZE 3; NC083T / METHA SHORT HIP STEM, CAP SIZE 3; NC087T / METHA NECK 12/14 135°/7.5°L ANTE-R RETRO; NC088K / METHA NECK 12/14 135°/0°
Patient Outcome(s) Other;
Patient Age68 YR
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