MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE HA CTD ACET SHELL 56MM; PROSTHESIS,HIP,HEMI-,TRUNNION-BEARING,FEMORAL,METAL/POLYACETAL

Catalog Number 71331956

Device Problem Incomplete or Inadequate Connection (4037)

Patient Problems Tissue Damage (2104); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2020

Event Type  Injury  

Event Description

It was reported that during a thr surgery, after reamed, trialled and implanted a r3 56mm 3 hole shell, the surgeon attempted to then insert a r3 liner 32mm x 56mm but found the liner did not seat completely.The surgeon reported that the liner looked flush and clicked slightly but did not feel locked and it was easy to dislodge again.A second r3 32mm id 56mm od liner was opened and had the same issue, but the surgeon then removed the r3 3 hole ha ctd acetabular shell 56mm and implanted a r3 56mm no hole shell.Then, the surgeon attempted to seat the second liner he had opened and this seated as expected with a click and was flush with the shell.It also did not dislodge easily.The surgeon reported he believed it was an issue with the r3 hole shell and the liner not seating correctly within that shell.Once he changed to another shell the liner seated as expected.The procedure was finished with a surgical delay of less than 30 minutes.No injury to the patient was reported.

• Brand Name: R3 3 HOLE HA CTD ACET SHELL 56MM
• Type of Device: PROSTHESIS,HIP,HEMI-,TRUNNION-BEARING,FEMORAL,METAL/POLYACETAL
• 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 ; 1450 brooks rd.; memphis, TN 38116
• MDR Report Key: 10558478
• MDR Text Key: 207687267
• Report Number: 1020279-2020-04741
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71331956
• Device Lot Number: 18MM14750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 01/04/2022
• Supplement Dates FDA Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2018
• 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
• Patient Outcome(s): Other