MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY HO POROUS SZ 6; PROSTHESIS, HIP, SEMI-CONSTRAINED.

Model Number	71356106
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tha surgery had been performed on (b)(6) 2009, the neck of an anthology ho porous sz 6 stem fractured.A revision surgery was performed on (b)(6) 2021 to explant the stem.The patient outcome is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, to date, the requested surgical records and x-rays have not been provided, therefore, a thorough medical assessment cannot be rendered.The patient impact and clinical root cause of the fractured stem and revision, cannot be determined.Should additional clinically relevant documentation become available, the clinical/medical task may be re-opened.No further assessment is warranted at this time.A review of the complaint history did not reveal additional complaints for the listed device.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to traumatic injury, abnormal loading of limb or excessive forces applied to implant.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, 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: ANTHOLOGY HO POROUS SZ 6
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED.
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11773667
• Report Number: 1020279-2021-03736
• Device Sequence Number: 17088448
• Product Code: MRA
• UDI-Device Identifier: 03596010567888
• UDI-Public: 03596010567888
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K052792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71356106
• Device Catalogue Number: 71356106
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 08/13/2021
• 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
• Patient Weight: 121