MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71335760
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 36/60 20 degree liner was placed in a 60mm r3 housing.Once the surgeon had impacted the liner, he pushed it away and the blood/fluid squirted out from between the liner and the shell.After that, it impacted the liner a little more and he continued with the procedure (with the same device).There was no smith and nephew representative in the case.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that per complaint details, after impacting the liner into the shell, the surgeon pushed on the construct and ¿blood/fluid¿ squirted out from between the liner and the shell¿ which was ¿unusual for him¿.Reportedly the surgeon ¿impacted the liner some more and moved on with the procedure¿.Without the requested medical documentation, the root cause of the reported event could not be concluded.The patient impact beyond the reported event could not be determined as per complaint, the procedure was completed with the same device.No further medical assessment could be rendered at this time.Should additional clinically relevant documentation become available the medical investigation task may be re-evaluated.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 instructions for use revealed that this failure mode has been identified.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique, implant failure or design of device.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or 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 60MM
• 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: 10188004
• Report Number: 1020279-2020-02675
• Device Sequence Number: 19069532
• Product Code: MBL
• UDI-Device Identifier: 03596010598370
• UDI-Public: 03596010598370
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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 Expiration Date: 12/21/2025
• Device Model Number: 71335760
• Device Catalogue Number: 71335760
• Device Lot Number: 15MM14408
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: R3 SHELL; R3 SHELL
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention