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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTL. REV. STEM Ø16 MM; UNCEMENTED REVISION STEMS (TI6AL4V) DIA.16MM, H.180MM
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LIMACORPORATE S.P.A. SMR CEMENTL. REV. STEM Ø16 MM; UNCEMENTED REVISION STEMS (TI6AL4V) DIA.16MM, H.180MM Back to Search Results
Model Number 1308.15.166
Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584); Appropriate Term/Code Not Available (3191)
Patient Problems Failure of Implant (1924); Joint Dislocation (2374)
Event Date 10/09/2018
Event Type  Injury  
Manufacturer Narrative
We will submit a final mdr once the investigation will be concluded.
 
Event Description
Revision surgery due to loosening of the stem (code 1308.15.166, lot# 1306663) and dislocation, performed on (b)(6) 2018.Previous surgery performed on (b)(6) 2018.According to the info reported, this was the 4th revision surgery for this patient and previous revision was due to periprosthetic fracture.Moreover, after previous revision, surgeon commented he was concerned about humeral implant stability.During this surgery the humeral components have been replaced (stem was replaced with 13mm x 150mm cemented revision stem) and the 44mm corrective glenosphere (code 1374.50.444, lot# 1706116) was replaced with a 40mm small-r eccentrical glenosphere with lateralizing custom made connector.Event happened in (b)(6).
 
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Brand Name
SMR CEMENTL. REV. STEM Ø16 MM
Type of Device
UNCEMENTED REVISION STEMS (TI6AL4V) DIA.16MM, H.180MM
Manufacturer (Section D)
LIMACORPORATE S.P.A.
via nazionale 52
villanova di san daniele, udine 33038
IT  33038
MDR Report Key8041543
MDR Text Key126238471
Report Number3008021110-2018-00098
Device Sequence Number0
Product Code KWS
PMA/PMN Number
K113523
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2018
Is this an Adverse Event Report? Yes
Device Operator No Information
Device Model Number1308.15.166
Device Lot Number1306663
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number0
Patient Outcome(s) Required Intervention;
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