MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE HA CTD ACET SHELL 54MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED

Catalog Number 71331954

Device Problem Failure to Align (2522)

Patient Problem Failure of Implant (1924)

Event Date 09/18/2019

Event Type  Injury  

Manufacturer Narrative

Internal reference number: case-(b)(4).

Event Description

It was reported that, after tha had been performed on (b)(6) 2018, the patient experienced malalignment of the cup. A revision surgery was performed on (b)(6) 2019 where r3 3 hole ha ctd acet shell 54mm, oxinium fem hd 12/14 32mm +4 and r3 0 degree xlpe lnr 32mm x 54mm were explanted. Patients current health status 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.

• Brand Name: R3 3 HOLE HA CTD ACET SHELL 54MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; brooks rd. 1450; memphis 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin; austin, TX 78735 ; 5123913905
• MDR Report Key: 12252151
• MDR Text Key: 264275055
• Report Number: 1020279-2021-06138
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K201701
• Number of Events Reported: 1
• 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 Received: 07/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 71331954
• Device Lot Number: UNKNOWN
• 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 Received: 08/25/2021
• 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: 07/30/2021 Patient Sequence Number: 1

Treatment

OXINIUM FEM HD 12/14 32MM +4/UNKNOWN; POLARSTEM STEM STD TI/HA 01 NON-CEM/UNKNOWN; R3 0 DEGREE XLPE LNR 32MM X 54MM/UNKNOWN