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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR PLUS HA SO STEM SZ 13 PRSTHSS, HP, SM-CNSTRND, NCMNTD, MTL/PLYMR, NN-PRS, CLCM-PHSPHT

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SMITH & NEPHEW, INC. SYN POR PLUS HA SO STEM SZ 13 PRSTHSS, HP, SM-CNSTRND, NCMNTD, MTL/PLYMR, NN-PRS, CLCM-PHSPHT Back to Search Results
Catalog Number 71309013
Device Problem Connection Problem (2900)
Patient Problems Failure of Implant (1924); Injury (2348)
Event Date 05/11/2020
Event Type  Injury  
Event Description
It was reported that during a thr the stem went further than the broach. Surgeon had to go up to a size 15 synergy from a 13. Les than 30 minutes delay reported, and a backup device was available.
 
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Brand NameSYN POR PLUS HA SO STEM SZ 13
Type of DevicePRSTHSS, HP, SM-CNSTRND, NCMNTD, MTL/PLYMR, NN-PRS, CLCM-PHSPHT
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
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10122972
MDR Text Key194124258
Report Number1020279-2020-02005
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002996
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71309013
Device Lot Number19LM17047
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/27/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/25/2019
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: 06/05/2020 Patient Sequence Number: 1
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