MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG BICON CE/CE CE/PE INSERT STD 5/28NON-CEM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 75003609

Device Problems Fracture (1260); Deformation Due to Compressive Stress (2889)

Patient Problem Failure of Implant (1924)

Event Date 06/06/2023

Event Type  Injury  

Event Description

It was reported that, after a thr surgery had been performed on an unknown date, the patient experienced the breakage of an unkn bicon-plus ceramic/pe insert.This adverse event was solved by revision surgery performed on (b)(6) 2023.Current health status of patient is unknown.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

Results of investigation: it was reported that, after a total hip replacement surgery had been performed on an unknown date, the patient experienced undescribed symptoms/adverse event.A revision surgery performed on (b)(6) 2023.A breakage of a bicon ce/ce ce/pe insert std 5/28non-cem was reported by the customer; however, the visual inspection reveals the item is worn instead of broken.The complaint device used in treatment was returned for investigation (additionally, a ceramic femoral head was returned as well).A visual evaluation of the bicon ce/ce ce/pe insert std 5/28non-cem was conducted, and it was concluded that it was deformed and worn.A review of the production documentation was not possible since the serial number on the device could not be extracted as it is fixated to the outer pe-shell and cannot be separated from each other.The complaint history review for the complaint device revealed no additional complaints for the affected batch nor additional complaints for the same product number over the past 12 months with similar failure mode.A review of past corrective actions was performed.No further escalation is required.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.The instructions for use (lit.No.12.23, ed.03/21) states "naturally worn" as a ¿potential medical device problem¿ in combination with the implantation of a hip prosthesis.No clinically sufficient data was provided to perform a medical investigation.The complaint device was sent for evaluation to the supplier and it was found that there are erratic signs of metal transference in the surface of the femoral head and in the surface of the insert, which are likely produced by chafing between the metallic instruments and the implants during the surgical procedures.On the polished surface of the insert and on the outer surface of the femoral head, areas with increase wear were found in the form of surface deterioration and material loss.On the rim and outer surface of the pe-shell, scratches can be found and can be probably caused by the surgical tools.Based on the available information it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.The root cause of the reported event remains undetermined.Recurring subluxations in combination with the long implantation duration of the implants can be stated as contributing factors.The need for further actions is not indicated.Nevertheless, smith+nephew will continue to monitor this device for similar issues.The returned device will be retained.

Event Description

It was reported that, after a thr surgery had been performed on an unknown date, the patient experienced undescribed symptoms.Adverse event.This adverse event was addressed by revision surgery performed on (b)(6) 2023.A breakage of a bicon ce/ce ce/pe insert std 5/28non-cem was reported by the customer; however, the visual inspection reveals the item is worn instead of broken.Current health status of patient is unknown.

Manufacturer Narrative

Corrected data: h6 (type of investigation).Updated results of investigation: it was reported that, after a total hip replacement surgery had been performed on an unknown date, the patient experienced undescribed symptoms.Adverse event.This adverse event was addressed by revision surgery performed on (b)(6) 2023.A breakage of a bicon ce/ce ce/pe insert std 5/28non-cem was reported by the customer; however, the visual inspection reveals the item is worn instead of broken.The complaint device used in treatment was returned for investigation (additionally, a ceramic femoral head was returned as well).A visual evaluation of the bicon ce/ce ce/pe insert std 5/28non-cem was conducted, and it was concluded that it was deformed and worn.All of the following tasks make reference to the insert: a review of the production protocols and the acceptance certificate was performed.The quality documents did not detect any deviation that could have contributed to the reported failure mode.The complaint history review for the complaint device revealed no additional complaints for the affected batch nor additional complaints for the same product number over the past 12 months with similar failure mode.A review of past corrective actions was performed.No further escalation is required.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.The instructions for use (lit.No.12.23, ed.03/21) states "naturally worn" as a ¿potential medical device problem¿ in combination with the implantation of a hip prosthesis.No clinically sufficient data was provided to perform a medical investigation.The complaint device was sent for evaluation to the supplier and it was found that there are erratic signs of metal transference in the surface of the femoral head and in the surface of the insert, which are likely produced by chafing between the metallic instruments and the implants during the surgical procedures.On the polished surface of the insert and on the outer surface of the femoral head, areas with increase wear were found in the form of surface deterioration and material loss.On the rim and outer surface of the pe-shell, scratches can be found and can be probably caused by the surgical tools.Based on the available information it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.The root cause of the reported event remains undetermined.Recurring subluxations in combination with the long implantation duration of the implants can be stated as contributing factors.The need for further actions is not indicated.Nevertheless, smith+nephew will continue to monitor this device for similar issues.The returned device will be retained.

• Brand Name: BICON CE/CE CE/PE INSERT STD 5/28NON-CEM
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17210946
• MDR Text Key: 317985924
• Report Number: 9613369-2023-00166
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 07611996002850
• UDI-Public: 7611996002850
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 75003609
• Device Lot Number: 9904.52.1201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 06/27/2023
• Supplement Dates Manufacturer Received: 10/06/2023; 03/20/2024
• Supplement Dates FDA Received: 10/11/2023; 03/22/2024
• 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 Outcome(s): Required Intervention