MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 50MM; PRSTHSS, HIP,SMI-CNSTRIND, UNCMNTD, MTL/PLYMR, POROUS

Model Number 71337650

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2019

Event Type  malfunction  

Event Description

It was reported that during surgery the outer cup was implanted and the liner cannot be locked.Another cup and liner were used to complete the surgery.Two hours of delay 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 have signs of damage from implantation and the attempted liner insertion and extraction.The devices were manufactured in 2018 and 2019.A dimensional inspection was performed and found the liners to be within specification and the shell to be out of specification, which confirmed the stated failure mode.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.The potential probable cause of the reported event is likely a manufacturing process error.Based on this investigation, the need for corrective action is 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.

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 have signs of damage from implantation and the attempted liner insertion and extraction.The devices were manufactured in 2018 and 2019.A dimensional inspection was performed and found the liners to be within specification and the shell to be out of specification, which confirmed the stated failure mode.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.The potential probable cause of the reported event is likely a manufacturing process error.Based on this investigation, the need for corrective action is 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 50MM
• Type of Device: PRSTHSS, HIP,SMI-CNSTRIND, UNCMNTD, MTL/PLYMR, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9372686
• MDR Text Key: 168675034
• Report Number: 1020279-2019-04151
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598486
• UDI-Public: 03596010598486
• 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,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71337650
• Device Catalogue Number: 71337650
• Device Lot Number: 18MM06587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2019
• Date Manufacturer Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1