MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71335754
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a thr procedure after implanting the corresponding 54 20 deg xlpe liner, as per surgical technique.When trial reduction was performed, it was noted that the liner had moved inside the cup as if it was undersized for the shell component (rotated as well as subsided within the shell).Other 54 20 deg liner was opened and used as per surgical technique without issue.A delay of less than or equal to 30 minutes was reported.No report of patient injury or harm was received.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.A visual inspection of the returned device shows damage on the splines, probably from the attempted insertion.The clinical medical investigation concluded that this complaint from australia reports that a 54 20 deg xlpe liner moved inside the cup almost as if it were undersized.The surgery was completed with another liner of the same size.It was not reported if any delay in the procedure was encountered.No harm or impact to the patient was reported.An intra-operative picture was provided but did not reveal a cause for the event.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A dimensional inspection found the device to be within specification.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.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 for this event could include a fit/ sizing issue or poor insertion technique.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; 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 54MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10697238
• Report Number: 1020279-2020-05498
• Device Sequence Number: 3058355
• Product Code: MBL
• UDI-Device Identifier: 03596010598349
• UDI-Public: 03596010598349
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2021

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: 71335754
• Device Catalogue Number: 71335754
• Device Lot Number: 19JM15401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention