MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY SO POR PL HA SZ 6; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71357006
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient suffered a femoral fracture during an operation.It is unknown if there was a delay or if a backup device was available.
Additional Manufacturer Narrative
It was reported that the patient suffered a femoral fracture during operation.The affected anthology porous plus standard offset stem, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part 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 product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported event could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.Possible causes could include but not limited to bone quality or surgical technique.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: ANTHOLOGY SO POR PL HA SZ 6
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038246
• MDR Report Key: 9253283
• Report Number: 1020279-2019-03795
• Device Sequence Number: 16734953
• Product Code: JDI
• UDI-Device Identifier: 03596010559494
• UDI-Public: 03596010559494
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K052792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2023

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: 71357006
• Device Catalogue Number: 71357006
• Device Lot Number: 17HM06396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 03/11/2020; 05/26/2023
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 03/13/2020; 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown