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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE HA CTD ACET SHELL 48MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. R3 0 HOLE HA CTD ACET SHELL 48MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71332248
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Joint Dislocation (2374); Subluxation (4525)
Event Date 11/23/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that, after tha had been performed on (b)(6) 2018, the patient experienced dislocation/subluxation. Therefore, a revision surgery was performed on (b)(6) 2018 where r3 0 hole ha ctd acet shell 48mm ((b)(4)), r3 20 deg xlpe acet lnr 28mm x 48mm ((b)(4)), oxinium fem hd 12/14 28mm +0 ((b)(4)) and polarstem stem std ti/ha 01 non-cem ((b)(4)) were explanted. The current health status of the patient is unknown. This information was provided by the national joint registry for england, wales, northern ireland and the isle of man supplier feedback; therefore, further information is not available.
 
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Brand NameR3 0 HOLE HA CTD ACET SHELL 48MM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Manufacturer (Section D)
SMITH & NEPHEW, INC.
brooks rd. 1450
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 Key12239802
MDR Text Key263894815
Report Number1020279-2021-06067
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K201701
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number71332248
Device Lot NumberUNKNOWN
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 Received08/25/2021
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 Initial

Patient Treatment Data
Date Received: 07/28/2021 Patient Sequence Number: 1
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