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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN SEL II POR SO 10/12 SZ 13 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

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SMITH & NEPHEW, INC. SYN SEL II POR SO 10/12 SZ 13 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
Catalog Number 71305413
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Ambulation Difficulties (2544)
Event Date 10/02/2020
Event Type  Injury  
Event Description
It was reported that, after a tha had been performed, the patient reported walking difficulty due to angle mistakes that were made on surgery. The surgeon has stated that the devices were not defective. A revision surgery was performed to explant the synergy sel ii por so 10/12 sz 13 stem. The patient outcome is unknown.
 
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Brand NameSYN SEL II POR SO 10/12 SZ 13
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
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 Key10766847
MDR Text Key214077441
Report Number1020279-2020-05968
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K970337
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71305413
Device Lot Number18GM07824
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 Received07/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/11/2018
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: 10/30/2020 Patient Sequence Number: 1
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