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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

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SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS STANDARD STEM 5 NON-CEMENTED PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER Back to Search Results
Model Number 75002703
Device Problem Loss of Osseointegration (2408)
Patient Problems Joint Dislocation (2374); Inadequate Osseointegration (2646)
Event Date 05/15/2014
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference: case (b)(4).
 
Event Description
It was reported that, after a left tha had been performed on (b)(6) 2008, the patient experienced loosening of the femoral stem and a joint dislocation. A revision surgery was performed on (b)(6) 2014 to treat this adverse event. During this procedure, all the tha prosthesis construct was explanted and replaced with an unspecified system. 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.
 
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Brand NameSL-PLUS STANDARD STEM 5 NON-CEMENTED
Type of DevicePROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER
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 Key14079994
MDR Text Key289062024
Report Number9613369-2022-00083
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,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2015
Device Model Number75002703
Device Catalogue Number75002703
Device Lot NumberF0804066
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/29/2008
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: 04/12/2022 Patient Sequence Number: 1
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