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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REFLECTION INTERFIT ACET SHELL THREE HOLE SZ 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. REFLECTION INTERFIT ACET SHELL THREE HOLE SZ 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71336048
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 01/18/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).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 dislocation.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
REFLECTION INTERFIT ACET SHELL THREE HOLE SZ 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
9013995009
MDR Report Key6316207
MDR Text Key67082121
Report Number1020279-2017-00095
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K960094
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 08/28/2017
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
Device Operator Health Professional
Device Catalogue Number71336048
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/04/2017
Initial Date FDA Received02/09/2017
Supplement Dates Manufacturer Received02/04/2017
Supplement Dates FDA Received08/28/2017
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
71333313, REFLECTION XLPE 26ID 20 DEGREE 46-48 OD
Patient Outcome(s) Hospitalization; Required Intervention;
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