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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW SIZE 14 STANDARD OFFSET SYNERGY POROUS PLUS HA FEMORAL COMPONENT; SIZE 14 STANDARD OFFSET SYNERGY POROUS PLUS HA FEMORAL COMPONENT, RIGHT HIP
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SMITH & NEPHEW SIZE 14 STANDARD OFFSET SYNERGY POROUS PLUS HA FEMORAL COMPONENT; SIZE 14 STANDARD OFFSET SYNERGY POROUS PLUS HA FEMORAL COMPONENT, RIGHT HIP Back to Search Results
Model Number 71309014
Device Problem Nonstandard Device (1420)
Patient Problem No Code Available (3191)
Event Type  Injury  
Event Description
Our office represents (b)(6) who received two smith and nephew, inc.Hip implants in 2009.For your reference, enclosed is a copy of the implant log sheet for mrs.(b)(6) right hip implant.We are currently working on obtaining the implant log sheet for mrs.(b)(6) left hip implant.Subsequent to mrs.(b)(6) hip implants, smith and nephew, inc.Withdrew the medical devices from the market.Since her hip implants in 2009, mrs.(b)(6) has experienced problems such that she has needed to revise on of her hips so far.After reviewing some of mrs.(b)(6) documents, we thought it would be appropriate to report mrs.(b)(6) problems with her hip implants to the fda.
 
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Brand Name
SIZE 14 STANDARD OFFSET SYNERGY POROUS PLUS HA FEMORAL COMPONENT
Type of Device
SIZE 14 STANDARD OFFSET SYNERGY POROUS PLUS HA FEMORAL COMPONENT, RIGHT HIP
Manufacturer (Section D)
SMITH & NEPHEW
MDR Report Key4684246
MDR Text Key15224918
Report NumberMW5042055
Device Sequence Number6
Product Code LZO
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Attorney
Type of Report Initial
Report Date 04/02/2015
8 Devices were Involved in the Event: 1   2   3   4   5   6   7   8  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date09/01/2019
Device Model Number71309014
Device Catalogue Number71309014
Device Lot Number09HM02429A
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/07/2015
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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