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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STEM INSERTER FRAME; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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SMITH & NEPHEW, INC. STEM INSERTER FRAME; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Catalog Number 71364008
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/16/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that one of the 2 pieces that allows the synergy femoral stem implant to seat on the inserter frame has broken off.No delay reported.No patient injuries reported.An s&n backup was available.
 
Additional Manufacturer Narrative
The associated complaint device was not returned.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.
 
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Brand Name
STEM INSERTER FRAME
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9187051
Report Number1020279-2019-03633
Device Sequence Number14146818
Product Code JDI
UDI-Device Identifier03596010199249
UDI-Public03596010199249
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K123598
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 11/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number71364008
Initial Date Received by Manufacturer 09/16/2019
Supplement Date Received by Manufacturer09/16/2019
Initial Report FDA Received Date10/14/2019
Supplement Report FDA Received Date11/07/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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