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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS INTEGR MIA STEM WITH TI/HA 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL, CEMENTED OR NON-POROUS, UNCEMENTED
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SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS INTEGR MIA STEM WITH TI/HA 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL, CEMENTED OR NON-POROUS, UNCEMENTED Back to Search Results
Model Number 11000426
Device Problem Loss of Osseointegration (2408)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description
Revision surgery due to missing osseointegration of the sl-plus mia stem and the ep-fit shell.No luxations happened, leg lenght discrepancies of 4 cm.
 
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Brand Name
SL-PLUS INTEGR MIA STEM WITH TI/HA 3
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL, CEMENTED OR NON-POROUS, UNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS AG
oberneuhofstrasse 10d
baar 6340
SZ  6340
MDR Report Key7420932
MDR Text Key105116338
Report Number9613369-2018-00020
Device Sequence Number1
Product Code LZO
UDI-Device Identifier07611996092783
UDI-Public07611996092783
Combination Product (y/n)N
PMA/PMN Number
K122296
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date08/20/2021
Device Model Number11000426
Device Catalogue Number75000176
Device Lot NumberA1410803
Was Device Available for Evaluation? No
Date Manufacturer Received04/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CERAMIC BALL HEAD 36M, PART 75007442, LOT C1516537; CERAMIC INSERT DELTA, PART 75007457, LOT E1411664; EP-FIT SHELL TI-PLASMA, PART75003903, LOT D1601575; CERAMIC BALL HEAD 36M, PART 75007442, LOT C1516537; CERAMIC INSERT DELTA, PART 75007457, LOT E1411664; EP-FIT SHELL TI-PLASMA, PART75003903, LOT D1601575
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Weight43
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