MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG BICON-PLUS TITANIUM SHELL 5-56 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 75003742

Device Problems Loss of Osseointegration (2408); Migration (4003)

Patient Problems Inadequate Osseointegration (2646); Joint Laxity (4526); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, after a thr surgery that had been performed on (b)(6)2008, the patient experienced a mobilization of the acetabular cup.This adverse event was solved via revision surgery performed on (b)(6)2023, in which a bicon-plus titanium shell 5-56 non-cem, a metal metal ball head 28s cone 12/14, and bicon-plus insert were explanted.The current health status of the patient is unknown.

Manufacturer Narrative

Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: it was reported that, after a total hip replacement surgery, the patient experienced a mobilization of the acetabular cup.This adverse event was solved via revision surgery, in which a bicon-plus titanium shell 5-56 non-cem, a metal metal ball head 28s cone 12/14, and bicon-plus insert were explanted.The current health status of the patient is unknown.The device used in treatment was not returned for investigation.A product evaluation was not possible.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.The review of historical complaints for the alleged device revealed no additional similar complaints reported for the same batch, and one additional similar 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 "osseointegration problem/loosening of implant not related to bone-ingrowth" as a ¿potential medical device problems¿ resulting from a hip arthroplasty.No clinically sufficient data was provided to perform a medical investigation.The performed investigation does not lead to an accurately determined cause.There is no evidence that the reported devices failed to meet manufacturing specifications upon release for distribution.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event.There is no need for further actions because of the limited information provided.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.Corrected data: b1 (type of event), h6 (health effect - clinical code, medical device problem code).

• Brand Name: BICON-PLUS TITANIUM SHELL 5-56 NON-CEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, 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: 16869458
• MDR Text Key: 314566228
• Report Number: 9613369-2023-00143
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2015
• Device Catalogue Number: 75003742
• Device Lot Number: D0804032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2008
• 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
• Treatment: BICON-PLUS PE INSERT ANTIL 5/28 NON-CEM, LOT#:0411; METAL METAL BALL HEAD 28S CONE 12/14, LOT#:C080126
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85 YR