MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG BICON-PLUS SHELL; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number UNKNOWN

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

Patient Problem Insufficient Information (4580)

Event Date 05/14/2014

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Vavrík, p., landor, i., popelka, s., fialka, r., & hach, j.(2014).The national register of joint replacements of the czech republic.Acta chirurgiae orthopaedicae et traumatologiae cechoslovaca, 81, 3-68.

Event Description

It was reported that, on the literature review ""the national register of joint replacements of the czech republic: hip joint replacements - selected outputs and their analysis for the period 2003-2012."", a total of four thousand six hundred twenty four (4624) patients underwent an index thr procedure during which a bicon plus prosthesis was implanted as acetabular component.From this group, a total of thirty nine (39) patients required a revision surgery due to reasons that were not specified within the report.Eighteen (18) from the thirty nine (39) revised patients were initially categorized under an older type of bicon-plus prosthesis classification, but the identity of these devices was not provided.As this data was pulled from the national register of joint replacements of the czech republic, any additional details related to these instances and to the clinical course of each patient is not available.

Manufacturer Narrative

According to data obtained from "the national register of joint replacements of the czech republic: hip joint replacements - selected outputs and their analysis for the period 2003-2012." [1], a total of four thousand six hundred twenty four (4624) patients underwent an index total hip replacement procedure during which a bicon plus prosthesis was implanted as acetabular component.From this group, a total of thirty nine (39) patients required a revision surgery due to reasons that were not specified within the report.Eighteen (18) from the thirty nine (39) revised patients were initially categorized under an older type of bicon-plus prosthesis classification, but the identity of these devices was not provided.The complaint device, used in treatment, was not received for investigation and a visual inspection could not be performed.The exact part and batch number of the device is not known.Therefore, the batch record review could not be performed and it is not possible to investigate whether the reported devices met manufacturing specifications upon release for distribution.A complaint history review was performed.The occurrence of the reported failure mode is within its expected risk level as per risk management.Furthermore, the ifu indicates several possible adverse effects resulting from a hip arthroplasty.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Due to insufficient information it is not possible to perform a review of past corrective actions.For the medical investigation, no relevant supporting clinical information could be provided.Therefore, a thorough clinical assessment cannot be performed at this time.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined.Should any additional clinical information be provided, this complaint will be re-evaluated.Based on the performed investigations, a relationship between the reported devices and the reported incidents cannot be excluded, but the root cause of the problem stays undetermined due to insufficient information.A relationship between the reported event and the device cannot be confirmed.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.To date, no further actions will be taken.Smith and nephew will monitor the devices for further similar issues.Internal complaint reference number: case-(b)(4).

• Brand Name: BICON-PLUS SHELL
• 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: 15535528
• MDR Text Key: 301097576
• Report Number: 9613369-2022-00538
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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
• Report Date: 10/25/2022

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 Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2022
• Initial Date FDA Received: 10/04/2022
• Supplement Dates Manufacturer Received: 10/10/2022
• Supplement Dates FDA Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Required Intervention