MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG BICON-PLUS TI SHELL POROSIS 3-49 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 75003776

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Insufficient Information (4580)

Event Date 09/13/2022

Event Type  Injury  

Event Description

It was reported that, according to data obtained from the australian orthopaedic association national joint replacement registry (aoanjrr), a total of 39 primary total conventional hip replacement procedures with the bicon-plus shell system were studied in a period of time between (b)(6) 1999 and (b)(6) 2022.From this cohort, 1 patient required a revision surgery of the acetabular component due to an unspecified adverse event related to an alleged incorrect sizing.The outcome of the patient is unknown.As the data was extracted from the aoanjrr, no further information is available.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: according to data obtained from the australian orthopedic association national joint replacement registry (aoanjrr) [1], a total of 39 primary total conventional hip replacement procedures with the bicon-plus shell system were studied in a period of time between 1-sep-1999 and 12-sep-2022.From this cohort, 1 patient required a revision surgery of the acetabular component due to an unspecified adverse event related to an alleged incorrect sizing.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, insufficient information was made available to determine the revision of ifu applicable to the device at the time of manufacturing.However, a review of current revision was conducted and the ifu lists 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.[1]: australian orthopaedic association national joint replacement registry (aoanjrr).Hip, knee & shoulder arthroplasty: 2022 annual report, adelaide; aoa, 2022: 1-487.

• Brand Name: BICON-PLUS TI SHELL POROSIS 3-49 NON-CEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: 15540271
• MDR Text Key: 301155201
• Report Number: 9613369-2022-00554
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07611996044263
• UDI-Public: 7611996044263
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 75003776
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2022
• 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): Required Intervention; Hospitalization