MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY HO POR PL HA SZ 12; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Model Number 71357112

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

It was reported that, after a right tha surgery was performed on the 28-aug-2008 due to osteoarthritis, the patient experienced in 2017, a proximal femur fracture which was treated conservatively.No further information available.

Manufacturer Narrative

Internal reference: case (b)(4).

Manufacturer Narrative

The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the blood loss and subsequent blood transfusion intraoperatively is likely related to the procedure and not the implant.It is unknown if the stated position of the acetabular component was a migration since implantation and if it led to accelerated wear and the elevated cobalt levels and intraoperative findings of trunnionosis, pseudotumor, osteolysis, yellowish, blackish synovial fluid as well as the previous fracture and subsequent fracturing off of the greater trochanter.Based on the limited information provided, the clinical root cause of the report clinical reactions cannot be confirmed.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond revision and expected transient post-op convalescence period cannot be determined.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history based on the historical data revealed a similar event for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for total hip systems revealed that trauma, strenuous activity, patient non-compliance, etc.Can increase risk of femoral fractures.This has been identified in warnings and precautions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, patient medical history, and/or bone quality.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.We consider this investigation closed.

• Brand Name: ANTHOLOGY HO POR PL HA SZ 12
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16876256
• MDR Text Key: 314634610
• Report Number: 1020279-2023-00977
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 03596010559678
• UDI-Public: 03596010559678
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2023

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
• Device Expiration Date: 01/08/2016
• Device Model Number: 71357112
• Device Catalogue Number: 71357112
• Device Lot Number: 06AM04685A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2023
• Initial Date FDA Received: 05/05/2023
• Supplement Dates Manufacturer Received: 06/07/2023
• Supplement Dates FDA Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male