MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 56MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Model Number 71335756

Device Problem Incomplete or Inadequate Connection (4037)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2020

Event Type  malfunction  

Event Description

It was reported during the procedure thr that the r3 liner would not seat in the shell.The procedure was completed without delay and with a backup from smith & nephew.No patient injury or other complications were reported.

Event Description

It was reported during the procedure thr that the r3 liner would not seat in the shell.The procedure was completed without delay and backup from smith & nephew was available to finish the surgery.The surgeon did not blame the device and was satisfied with the surgical outcome.No patient injury or other complications were reported.

Manufacturer Narrative

Updated b5: description of problem.

Manufacturer Narrative

H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection was completed but could not confirm the state failure.There are gouges and minor damage to the liner.The liner exhibits deep scratches/deformation on the id and id rim.A dimensional analysis could not be completed due to damage to the liner from attempting to insert it into the shell.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: R3 20 DEG XLPE ACET LNR 36MM X 56MM
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10708441
• MDR Text Key: 212281950
• Report Number: 1020279-2020-05585
• Device Sequence Number: 1
• Product Code: JDH
• UDI-Device Identifier: 03596010598356
• UDI-Public: 03596010598356
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71335756
• Device Catalogue Number: 71335756
• Device Lot Number: 20AM23159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Date Manufacturer Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1