Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS MIA STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL, CEMENTED OR NON-POROUS, UNCEMENTED
  • 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
 

SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS MIA STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL, CEMENTED OR NON-POROUS, UNCEMENTED Back to Search Results
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 05/08/2018
Event Type  Injury  
Event Description
Neck fracture on the stem.(sl mia stem + merete head 5xl no part number and serial number available).It has not been reported whether a revision surgery has taken place.
 
Manufacturer Narrative
Results of investigation: a revision surgery due to the neck fracture of a sl.Plus mia stem was reported.A sl-plus mia stem along with a large offset third party ball head were returned for investigation.No part number or batch number are available.The reported neck fracture was confirmed.A fracture analysis revealed a fatigue fracture with a ductile residual fracture.No indications of material homogeneity were detected.Based on the available information no specific root cause for the fracture can be determined.Please be nonetheless advised that the combination of a sl-plus mia stem with a third party ball head constitutes an off-label use.Furthermore it cannot be excluded the large offset of the third party ball head contributed significantly to the fracture of the stem.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SL-PLUS MIA STEM
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 Key7572412
MDR Text Key110163884
Report Number9613369-2018-00033
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2018
Initial Date Manufacturer Received 05/17/2018
Initial Date FDA Received06/06/2018
Supplement Dates Manufacturer Received05/17/2018
Supplement Dates FDA Received08/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
-
-