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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TITANIUM MODULAR HEAD SLV 12/14 TPR +8 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. TITANIUM MODULAR HEAD SLV 12/14 TPR +8 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Model Number 71344249
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Joint Dislocation (2374)
Event Date 11/15/2021
Event Type  Injury  
Event Description
It was reported that, after a thr performed on 2013, the patient experienced recurrent dislocations. This adverse event was solved by a revision surgery on (b)(6) 2021, in which 40 mm oxonium modular head and r3 20 deg +4 xlpe acet lnr 40 mm x 58 od were explanted. Current health status of patient is unknown. Previously, on 2014, the patient had a revision surgery also due to dislocation.
 
Manufacturer Narrative
Internal complaint reference (b)(4).
 
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Brand NameTITANIUM MODULAR HEAD SLV 12/14 TPR +8
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, 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
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key12916377
MDR Text Key281594296
Report Number1020279-2021-08479
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K093363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number71344249
Device Catalogue Number71344249
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/17/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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