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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 ACETABULAR SHELL 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
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SMITH & NEPHEW, INC. R3 ACETABULAR SHELL 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 07/23/2015
Event Type  Injury  
Event Description
Third revision occured due to loosening of the cup.1st revision occured due to periprosthetic neck fracture (submitted under 3005975929-2017-00001) and the 2nd was due to metallosis (submitted under 3005975929-2017-00003).
 
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Brand Name
R3 ACETABULAR SHELL 48MM
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
claudia de santis
schachenallee 29
aarau 5001
SZ   5001
0628320660
MDR Report Key6285923
MDR Text Key66029507
Report Number1020279-2017-00069
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092386
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date 07/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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
OXINIUM FEM HD 12/14 32MM: 71343200, LOT 13MM10387; R3 20 DEG +4 XLPE ACET LNR : 71337948, LOT 07MM016; REF SPHER HEAD SCREW 15MM: 71332515, LOT 12GM12909
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age66 YR
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