MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY SO POROUS SIZE 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Model Number	71356003
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a left total hip replacement, utilizing one (1) anthology so porous size 3, patient had tight femoral canal.Distal reamers were used initially.It was broached to a size three.Trialed size 3 standard offset anthology stem was opened.Implant was inserted and attempted to advance with impactor and mallet.Implant sitting around 5cm proud, and did not advance any further.It was attempted to remove the implant to see if there was anything in femoral canal that was preventing implant insertion.Surgeon was unable to remove the implant.It took approx.30-45 minutes to remove implant using flexible osteotome.The broach and implant were checked - both size 3.The femoral canal was inspected, and it was clear.It was re broached with size 2 and size 3 with no issues.The implant was reinserted and again would not advance and it was difficult to remove.Once the implant was removed, it was inspected alongside broach and dr snyman reported slight size difference in broach and implant which he believes was causing the issue.Canal broached further to accommodate implant.Implant was inserted and advanced to appropriate depth.The procedure was performed, after a significant delay, using the same device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the implant, could not be returned for evaluation.The instrument was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the provided x-rays were reviewed and cannot be used to confirm the stem size as they are not originals and do not have reference measurements.The clinical root cause of the reported events cannot be definitively concluded based on the provided information.Procedural variance cannot be ruled out as a possible contributing factor.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For anthology so porous size 3 a review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.For anthology std broach size 3 a review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the risk management files 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 these products and event.For anthology so porous size 3 according to the inspection drawing, final inspection includes checking part geometries such as stem length and height for size verification with appropriate instrumentation.For anthology std broach size 3 according to inspection procedure, parts should be measured with a caliper and their configuration should be compared to print and routing.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include surgical technique used or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Should the instrument 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 SO POROUS SIZE 3
• Common Device Name: 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: 16771256
• Report Number: 1020279-2023-00871
• Device Sequence Number: 14237808
• Product Code: MRA
• UDI-Device Identifier: 03596010567734
• UDI-Public: 03596010567734
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K211176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71356003
• Device Catalogue Number: 71356003
• Device Lot Number: 21GM07880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 71365603/ANTHOLOGY STD BROACH SIZE 3.
• Patient Sex: Unknown