• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIMACORPORATE S.P.A. H-MAX S H-MAX S STANDARD UNCEMENTED STEMS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LIMACORPORATE S.P.A. H-MAX S H-MAX S STANDARD UNCEMENTED STEMS Back to Search Results
Model Number 4250.02.090
Device Problems Device Slipped (1584); Material Protrusion/Extrusion (2979)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
The check of dhr of the lot# (201109627) of stem involved did not show any anomaly. No other complaints have been reported on the lot# involved, on a total of (b)(4) h-max s femoral stems manufactured with this lot#. We will submit a final mdr once the investigation will be concluded.
 
Event Description
Hip revision surgery due to implant loosening after 71 months from primary surgery. According to the info reported, patient started feeling pain and so the stem, well fixed in the canal but slight wiggle at the top, was pulled out and a restoration stem was implanted. Even the original poly liner was replaced with a protruded poly liner. Event happened in (b)(6).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameH-MAX S
Type of DeviceH-MAX S STANDARD UNCEMENTED STEMS
Manufacturer (Section D)
LIMACORPORATE S.P.A.
via nazionale,52
villanova di san daniele, 33038
IT 33038
Manufacturer (Section G)
LIMACORPORATE S.P.A.
via nazionale,52
villanova di san daniele, 33038
IT 33038
Manufacturer Contact
giulio puppa
MDR Report Key6398526
MDR Text Key69738494
Report Number3008021110-2017-00012
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K112091
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4250.02.090
Device Lot Number201109627
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-