MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY HO POROUS SZ 7; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 71356107

Device Problem Peeled/Delaminated (1454)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Event Description

It was reported that, during thr surgery, the anthology ho porous sz 7 was removed after being inserted into the human body to change the size of the product, and it was found that the coating surface of the product was peeled off.Surgery was performed, after a non-significant delay, with a smith and nephew back-up device.Patient was not injured as consequence of this problem.

Manufacturer Narrative

H3, h6: the shipping information was provided and all efforts were made to locate the device, however the subject device was not made available to the designated complaint unit and thus a physical product evaluation could not be performed.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the dislocations and subsequent revision.The patient impact beyond the revision cannot be determined with the limited information.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 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.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.According with inspection, the visual inspection includes the verification of surface finish of part is per print and that all surface transitions blend uniformly.Also, material specification shall control the quality of manufacture of the plasma sprayed coatings on substrates, including the average coating thickness and the bond strength of the coating.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 damage during shipping or mishandling.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.

Manufacturer Narrative

H10.Additional information in d9.H3, h6.The associated device was returned and evaluated.The visual inspection revealed the coating is peeling off, scratches and gouges in the femoral component.An evaluation was made by our quality engineers and found that this product has excessive damage to the porous coating.This damage is too severe to have made it through our inspection process and would fail several checkpoint inspections prior to being shipped out.The porous coating had been properly adhered to the stem.The damage most likely occurred from a surgical instrument during surgery.The porous coating had been properly adhered to the stem.There is no reason to believe any other product has been affected in which we would need to provide action.No non conformance is needed.The clinical/medical investigation concluded that, based on the information provided no clinical factors were found which would have contributed to the reported events.The anthology ho porous is implantable, biocompatibility is not an issue.If retained micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.No further clinical/medical assessment is warranted at this time.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 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.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.According with inspection, the visual inspection includes the verification of surface finish of part is per print and that all surface transitions blend uniformly.Also, material specification shall control the quality of manufacture of the plasma sprayed coatings on substrates, including the average coating thickness and the bond strength of the coating.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should 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.H11.Corrected information in h6 (health effect - impact code).

• Brand Name: ANTHOLOGY HO POROUS SZ 7
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 15374703
• MDR Text Key: 299717451
• Report Number: 1020279-2022-03999
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010567895
• UDI-Public: 03596010567895
• Combination Product (y/n): N
• PMA/PMN Number: P030022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2023

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
• Device Operator: Health Professional
• Device Model Number: 71356107
• Device Catalogue Number: 71356107
• Device Lot Number: 20FM11667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/07/2022
• Supplement Dates Manufacturer Received: 03/24/2023; 07/21/2023
• Supplement Dates FDA Received: 03/27/2023; 07/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2020
• 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