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

Catalog Number 71331954

Device Problems Failure to Align (2522); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Deformity/ Disfigurement (2360); Insufficient Information (4580)

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.

Manufacturer Narrative

D4: lot number and expiration date.D10: lot number of concomitant devices.H4: manufacturing date.H6: clinical code, device problem code.

Manufacturer Narrative

Corrected data: a3 (gender), h6 (health effect - clinical code, investigation findings).Updated results of investigation: given the nature of the alleged incident, these devices, could not be returned for evaluation.The clinical/medical investigation concluded that, smith and nephew has not received the explanted devices and/or adequate materials to fully evaluate the complaint.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the r3 3 hole ha ctd acet shell, a review of complaint history for the part number over the past 18 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems revealed in the intraoperative section that the correct selection of the cup is important.Malpositioning of components may result in loosening, subluxation, dislocation and/or fracture of components.The component should be firmly seated with the component insertion instruments and stability verified.Failure to do so may result in implant failure and revision surgery.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include surgical technique used or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved, our investigation could not proceed.Should the devices or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/16/2023

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: Health Professional
• Device Catalogue Number: 71331954
• Device Lot Number: 18GM17028A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 71339554 / LOT: 18BM04492.; 71343204 / LOT: 18DM06469.; 75100462 / LOT: B1805556.; 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.; 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male