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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS STANDARD STEM 5 NON-CEMENTED PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

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SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS STANDARD STEM 5 NON-CEMENTED PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Back to Search Results
Model Number 75002703
Device Problem Loss of Osseointegration (2408)
Patient Problem Inadequate Osseointegration (2646)
Event Date 06/24/2019
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference: case (b)(4).
 
Event Description
It was reported that, after a right tha had been performed on (b)(6) 2010, the patient experienced loosening of the femoral stem and acetabular cup. A revision surgery was performed on (b)(6) 2019 to treat this adverse event. During this procedure, all components of the right tha hip construct were explanted. The patient's health status is not known. This information was provided by the (b)(6), following a review of the data conducted in september 2021. Further information will not become available.
 
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Brand NameSL-PLUS STANDARD STEM 5 NON-CEMENTED
Type of DevicePROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS AG
schachenallee 29
aarau CH-50 00
SZ CH-5000
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS AG
schachenallee 29
aarau CH-50 00
SZ CH-5000
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key14131567
MDR Text Key289446147
Report Number9613369-2022-00115
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K072852
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/15/2016
Device Model Number75002703
Device Catalogue Number75002703
Device Lot NumberF0900886
Was Device Available for Evaluation? No
Date Manufacturer Received03/22/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/16/2009
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: 04/16/2022 Patient Sequence Number: 1
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