MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 48MM; PRSTHSS, HP, SM-CNSTRND, UNCMNTD, MTL/PLYMR, PRS

Model Number 71337648

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 12/05/2019

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to dislocation.After the total hip replacement, the post-op x-rays showed that the liner didn't engage/ lock into the cup, it must have ¿popped¿ out.Explanted devices: liner, due to extensive damaged and the ball head as it was moving on the rim of the cup, also damaging it.

Manufacturer Narrative

The associated devices, used in treatment, were returned and evaluated.Only the head and liner were returned.A visual inspection of the returned devices could not confirm the stated failure mode.The head and liner are heavily damaged from implantation / insertion / extraction.The devices were manufactured in 2019.The clinical / medical investigation concluded that only one photo of the damaged device and two pages of chart sticks were provided for review.Without the relevant clinical information, a thorough medical investigation cannot be rendered.Should any additional medical information be provided, this complaint will be re-assessed.A dimensional inspection was attempted but the devices were too damaged to obtain accurate measurements.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 no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes of the reported event could include improper surgical technique or device selection.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.

• Brand Name: R3 20 DEG XLPE ACET LNR 32MM X 48MM
• Type of Device: PRSTHSS, HP, SM-CNSTRND, UNCMNTD, MTL/PLYMR, PRS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9530077
• MDR Text Key: 173100876
• Report Number: 1020279-2019-04631
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598479
• UDI-Public: 03596010598479
• Combination Product (y/n): N
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/14/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 71337648
• Device Catalogue Number: 71337648
• Device Lot Number: 19AM15710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 12/05/2019
• Supplement Dates FDA Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention