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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CPCS SS PRIM SO 12/14 SZ 0; COLLARLESS POLISHED CEMENTED HIP SYS.
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SMITH & NEPHEW, INC. CPCS SS PRIM SO 12/14 SZ 0; COLLARLESS POLISHED CEMENTED HIP SYS. Back to Search Results
Catalog Number 71312380
Device Problems Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395)
Patient Problems Injury (2348); No Code Available (3191)
Event Date 07/05/2016
Event Type  Injury  
Manufacturer Narrative
Customer indicated that there is no product/device to be returned for investigation analysis.
 
Event Description
It was reported a revision surgery was performed due to loosening.Cement debonding at both cement/implant and cement/bone interface.
 
Manufacturer Narrative
Additional information: type of reports, if follow-up, what type?, device evaluated by mfr?, evaluation codes.
 
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Brand Name
CPCS SS PRIM SO 12/14 SZ 0
Type of Device
COLLARLESS POLISHED CEMENTED HIP SYS.
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis
Manufacturer Contact
yagna angirish
1450 brooks rd
memphis, TN 38116
9013995009
MDR Report Key5836318
MDR Text Key50828191
Report Number1020279-2016-00584
Device Sequence Number1
Product Code JDH
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 06/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number71312380
Device Lot Number14GT43622
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/05/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
(B)(4)
Patient Outcome(s) Hospitalization; Required Intervention;
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