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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIMACORPORATE S.P.A. H-MAX S LATERALIZED UNCEMENTED STEM

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LIMACORPORATE S.P.A. H-MAX S LATERALIZED UNCEMENTED STEM Back to Search Results
Model Number 4251.20.110
Device Problems Inadequacy of Device Shape and/or Size (1583); Unintended Movement (3026)
Patient Problem Failure of Implant (1924)
Event Date 11/15/2016
Event Type  Injury  
Manufacturer Narrative
The check of the dhr of the lot # involved (stem: lot #201516301; head: lot# 201580046; acetabular cup: lot # 201508570; liner: lot # 201581452) did not show any anomalies on the overall number of pieces manufactured with these lot#. This is the first similar complaint reported on these lot #. We will submit a final mdr once our investigation is concluded.
 
Event Description
Hip revision surgery performed on (b)(6) 2016 due to subsidence of the stem. The primary surgery was performed on (b)(6) 2016 and the implanted prosthesis consisted of a h-max s stem, a ceramic femoral head and delta tt with pe liner. It was advised that the surgeon might have undersized the stem at the time of primary surgery. Event occurred in (b)(6).
 
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Brand NameH-MAX S LATERALIZED UNCEMENTED STEM
Type of DeviceH-MAX S LATERALIZED UNCEMENTED STEM
Manufacturer (Section D)
LIMACORPORATE S.P.A.
via nazionale 52
villanova di san daniele, udine 33038
IT 33038
Manufacturer Contact
giulio puppa
via nazionale, 52
villanova di san daniele, 33038
IT   33038
MDR Report Key6735526
MDR Text Key80776820
Report Number3008021110-2016-00119
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K160011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2020
Device Model Number4251.20.110
Device Lot Number201516301
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/21/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/30/2015
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: 07/24/2017 Patient Sequence Number: 1
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