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
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: PRSTHSS, HIP,SMI-CNSTRIND, UNCMNTD, MTL/PLYMR, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9372686
• Report Number: 1020279-2019-04151
• Device Sequence Number: 11407682
• Product Code: MBL
• UDI-Device Identifier: 03596010598486
• UDI-Public: 03596010598486
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 02/06/2020; 02/06/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 02/11/2020; 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1