MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY HO POR PL HA SZ 9; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71357109
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924)
Date of Event	09/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, after total hip replacement was performed on an unspecified date, the patient sustained a periprosthetic fracture following a fall.This adverse event was treated with a revision surgery conducted on (b)(6) 2021.Patient's current health status is unknown.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the failure mode was confirmed.The clinical/medical investigation concluded that x-ray image shows what appears to be a noncomminuted fracture of the proximal femur, cleaved medially.Reportedly, the root cause of the periprosthetic fracture and subsequent revision was a fall.The patient impact beyond the reported fall, fracture, and revision procedure could not be determined, as the patient status was unknown.No further medical assessment could be rendered at this time.Smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.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 or surgical technique.Based on this investigation, the need for corrective action is not indicated.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.

• Brand Name: ANTHOLOGY HO POR PL HA SZ 9
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12550868
• Report Number: 1020279-2021-07334
• Device Sequence Number: 14744821
• Product Code: JDI
• UDI-Device Identifier: 03596010559647
• UDI-Public: 03596010559647
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021

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 Expiration Date: 04/06/2026
• Device Model Number: 71357109
• Device Catalogue Number: 71357109
• Device Lot Number: 16DM06057
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 11/04/2021
• 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