MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 54MM; PRSTHSSHIPSMICNSTRINDUNEENTDMTALPLYMRPROUS

Model Number	71336454
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the reflection liner couldn't be implanted into the cup.Finally a r3 liner and cup were used to complete the surgery.No injury or impact to patient reported.Delay of 1 hour reported.
Additional Manufacturer Narrative
Additional information: d4, g2, g3, g5 and h4 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 some signs of damage from implantation / insertion / extraction.The devices were manufactured in 2019.A dimensional inspection was attempted on the liner but it was too damaged from the attempted insertion to obtain accurate measurements.A dimensional inspection of the shell found it to be within specification.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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.Some potential probable causes of the reported event could include improper insertion technique or device damaged during insertion.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: REF THREE HOLE SHELL 54MM
• Common Device Name: PRSTHSSHIPSMICNSTRINDUNEENTDMTALPLYMRPROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9482182
• Report Number: 1020279-2019-04435
• Device Sequence Number: 14449858
• Product Code: MBL
• UDI-Device Identifier: 03596010454362
• UDI-Public: 03596010454362
• Combination Product (Y/N): N
• PMA/510(K) Number: K960094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2020

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
• Operator of Device: Health Professional
• Device Model Number: 71336454
• Device Catalogue Number: 71336454
• Device Lot Number: 19DM21948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 04/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1