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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKN R3 METAL LINER IMPL

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SMITH & NEPHEW ORTHOPAEDICS LTD UNKN R3 METAL LINER IMPL Back to Search Results
Catalog Number UNKN01100907
Device Problem Biocompatibility (2886)
Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530)
Event Date 02/06/2020
Event Type  Injury  
Event Description
*us legal mdl* it was reported that, after a r3 tha construct had been implanted on an unknown date, the plaintiff experienced failed metal on metal articulation, elevated ion levels, pain, and disability. The plaintiff has failed the conservative nonsurgical management, which included ambulatory assistive devices, low impact exercise, and anti inflammatory medication. A revision surgery was performed on (b)(6) 2020 to treat these adverse events. The patient outcome is unknown.
 
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Brand NameUNKN R3 METAL LINER IMPL
Type of DeviceUNKN R3 METAL LINER IMPL
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house, spa park
leamington spa warwickshire CV31 3HL
UK CV31 3HL
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house, spa park
leamington spa warwickshire CV31 3HL
UK CV31 3HL
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key11910663
MDR Text Key253470072
Report Number3005975929-2021-00293
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKN01100907
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/31/2021 Patient Sequence Number: 1
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