MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71337654
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented a hip dislocation.This was resolved via closed reduction.
Additional Manufacturer Narrative
Results of investigation: it was reported that the patient presented a hip dislocation.This was resolved via closed reduction.The associated r3 20 deg acetabular liner and the oxinium femoral head, used in treatment, were not returned for evaluation as devices remain implanted.Therefore the product analysis could not be performed.The review of manufacturing records was conducted and it did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.Review of the instructions for use and risk management files identified the reported failure, dislocation, as potential adverse events.A medical analysis indicated that the provided surgical notes stated the patient¿s right hip was easily repined and stable to 60 degrees inward and inward rotation at 90 degree flex hip.Per communications the x-ray showed an unchanged position of the components.No additional freatment has been planned.Possible causes could include but are not limited to traumatic injury, patient anatomy or abnormal loading of limb.The event was reported as resolved.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: R3 20 DEG XLPE ACET LNR 32MM X 54MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9164261
• Report Number: 1020279-2019-03577
• Device Sequence Number: 16751628
• Product Code: MBL
• UDI-Device Identifier: 03596010598509
• UDI-Public: 03596010598509
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2020

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: 71337654
• Device Catalogue Number: 71337654
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 04/03/2020
• 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