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, INC. REF SPHER HEAD SCREW 30MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CA-P
  • 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, INC. REF SPHER HEAD SCREW 30MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CA-P Back to Search Results
Catalog Number 71332530
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994)
Date of Event 03/22/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a revision surgery occured due to breakage of screw.Patient complained of pain in (b)(6) 2017 but x-rays didn't show anything.Surgeon decided to operate as he was aware that the trochanter had a non-union.Intraoperatively it was discovered that 30mm spherical head screws had broken.Surgeon revised the cup, 5 fixation screws and the liner.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
REF SPHER HEAD SCREW 30MM
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CA-P
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6471715
Report Number1020279-2017-00245
Device Sequence Number582754
Product Code MEH
UDI-Device Identifier03596010460479
UDI-Public03596010460479
Combination Product (Y/N)N
Initial Reporter CountrySF
PMA/510(K) Number
K990666
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 08/31/2017
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
Operator of Device Health Professional
Device Catalogue Number71332530
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2017
Initial Date Received by Manufacturer 03/22/2017
Supplement Date Received by Manufacturer03/22/2017
Initial Report FDA Received Date04/07/2017
Supplement Report FDA Received Date08/31/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
R3 20DEG XLPEACET LNR 36MMX60MM, (B)(4)/14GM19376; R3 MULTIHOLE ACETAB SHELL60MM,(B)(4)/14DM02893; REF SPHER HEAD SCREW 15MM, (B)(4)/13MM11402; REF SPHER HEAD SCREW 20MM, (B)(4)/15CM17075; REF SPHER HEAD SCREW 20MM, (B)(4)/15CM17075; REF THREADED HOLE COVER, (B)(4)/15EM05045; UNKNOWN REF SPHER HEAD SCREW
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age73 YR
-
-