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

Catalog Number 75003742

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Inadequate Osseointegration (2646)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, a plaintiff underwent a primary left thr in 2017, and later experienced loosening of the bicon-plus titanium shell 5-56 non-cem and pain when walking.Therefore, a revision surgery was performed in 2019, during which the cup and head were exchanged with a larger cemented cup and 5 xl head.No further complications related to this adverse event were reported.

Manufacturer Narrative

Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: it was reported that, a plaintiff underwent a primary left total hip replacement in 2017, and later experienced loosening of the bicon-plus titanium shell 5-56 non-cem and pain when walking.Therefore, a revision surgery was performed in 2019, during which the cup and head were exchanged with a larger cemented cup and 5 xl head.The device intended for use 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 1 additional similar complaint 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 problem¿ in combination with the implantation of a hip prosthesis.Based on the limited information provided, the clinical root cause of the reported loosening could not be concluded.However, we are unable to rule out if the component loosening was a result from failure to achieve initial fixation and the patient¿s history of multiple revision surgeries as contributing factors to the reported events.Furthermore, it cannot be concluded there was a mal performance of the implant or an implant failure.The pain was likely the result of the component loosening.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 indicate factors which could have contributed to the reported event.There is no need for further actions.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.

• Brand Name: BICON-PLUS TITANIUM SHELL 5-56 NON-CEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 18897518
• MDR Text Key: 337590381
• Report Number: 9613369-2024-00023
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07611996044171
• UDI-Public: 7611996044171
• 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,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2023
• Device Catalogue Number: 75003742
• Device Lot Number: E1616859
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: PN: 71343608 / LOT: 17CM20206; PN: 75101936 / LOT: A1612824
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 60 KG