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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. POLARSTEM STEM STD TI/HA 0 NON-CEM PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

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SMITH & NEPHEW, INC. POLARSTEM STEM STD TI/HA 0 NON-CEM PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Back to Search Results
Model Number 75100463
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Failure of Implant (1924)
Event Date 11/26/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that, after thr surgery had been performed on (b)(6) 2021, the polyethylene ring separated from the cup. This adverse event was solved by a explanation on (b)(6) 2021. The current health status of patient is unknown.
 
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Brand NamePOLARSTEM STEM STD TI/HA 0 NON-CEM
Type of DevicePROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
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 Key13084285
MDR Text Key282773069
Report Number1020279-2021-08843
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number75100463
Device Catalogue Number75100463
Device Lot NumberB2018267
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/19/2020
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: 12/24/2021 Patient Sequence Number: 1
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