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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGEND HIP STEM 135DG COLLARLESS SIZE 9 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS,

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SMITH & NEPHEW, INC. LEGEND HIP STEM 135DG COLLARLESS SIZE 9 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, Back to Search Results
Catalog Number H0212.1359
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/17/2020
Event Type  malfunction  
Event Description
It was reported that, during thr procedure, the surgeon broached upto size 9 stem and felt perfect fit of the canal, reduced with the trials. Then went for the final implantation, opened same size 9 stem as per our surgical technique. But the original implant sinked in the femoral canal, not like the trial broach. Then when checking with the ml and ap dimension of the stem comparing with the trial broach, implant is comparatively smaller than the broach in both the aspect. The surgeon opened next size 10 stem and implanted without broaching, which perfectly fit the canal. Surgery was not delayed more than 30 min. The patient is fine.
 
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Brand NameLEGEND HIP STEM 135DG COLLARLESS SIZE 9
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS,
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
1450 brooks rd.
memphis, TN 38116
5123913905
MDR Report Key10681627
MDR Text Key211423001
Report Number1020279-2020-05401
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberH0212.1359
Device Lot NumberZA0024
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2020
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 Treatment Data
Date Received: 10/14/2020 Patient Sequence Number: 1
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