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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN R3 SHELL

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SMITH & NEPHEW, INC. UNKN R3 SHELL Back to Search Results
Catalog Number UNKN01100901
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Joint Dislocation (2374)
Event Date 04/21/2021
Event Type  Injury  
Event Description
It was reported that after around 13 years of being implanted by thr, an unknown r3 ceramic liner ((b)(4)), an unknown r3 shell ((b)(4)) and an unknown femoral head implant ((b)(4)) had to be explanted on the (b)(6) 2013 due to patient with chronic dislocation. It was reported that the patient was stable for several years after the revision surgery.
 
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Brand NameUNKN R3 SHELL
Type of DeviceUNKN R3 SHELL
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 Key11817209
MDR Text Key250369137
Report Number1020279-2021-04184
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKN01100901
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2021
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

Patient Treatment Data
Date Received: 05/13/2021 Patient Sequence Number: 1
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