MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 MULTI HOLE ACETABULAR SHELL 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number 71338666

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2019

Event Type  malfunction  

Event Description

It was reported that during surgery the implants did not seat.A back device was available and less than thirty minutes delay was reported.

Manufacturer Narrative

The associated devices, used in treatment, were returned and evaluated.A visual inspection of the returned devices could not confirm the stated failure mode.The devices had numerous scratches and nicks from the attempted implantation and extraction.The devices were manufactured in 2018.A dimensional inspection of the shells found the devices did not meet specification.A dimensional inspection of the liners found the devices did meet specification.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have reason to suspect that the product failed to meet product specifications at the time of manufacture.The potential probable cause for this event is likely a manufacturing process error.Based on this investigation, the need for corrective action is indicated.

• Brand Name: R3 MULTI HOLE ACETABULAR SHELL 54MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038
• MDR Report Key: 9820851
• MDR Text Key: 183303819
• Report Number: 1020279-2020-00834
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 00885556021804
• UDI-Public: 00885556021804
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71338666
• Device Catalogue Number: 71338666
• Device Lot Number: 18HM03836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 03/11/2020
• Supplement Dates Manufacturer Received: 01/03/2019; 01/03/2019; 12/06/2021; 12/06/2021; 09/27/2022
• Supplement Dates FDA Received: 03/11/2020; 04/14/2020; 12/05/2021; 12/06/2021; 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2331-2020
• Patient Sequence Number: 1
• Treatment: 71332754 / 18FM16740