MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG BICON-PLUS PE INSERT ANTIL 3/28 NON-CEM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 75003579

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

Patient Problems Joint Dislocation (2374); Insufficient Information (4580)

Event Date 08/16/2007

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Event Description

It was reported that, after 1090 primary tha surgeries in which a bicon-plus acetabular sub-system had been implanted, there has been 84 revision surgeries for unspecified reasons.This information was provided by the national joint registry of the (b)(6), following a review of the data conducted in september 2021.Inspection of the data shows that the calculated ptir (revision rate per one hundred patient years of implantation) of bicon-plus is above the average [071 (0.57-0.88)] for their group ptir¿s [0.38].

Event Description

It was reported that, after a left tha had been performed on (b)(6) 2003, the patient suffered a dislocation/subluxation.This event was addressed via revision surgery on (b)(6) 2007 to explant the bicon-plus pe insert antil 3/28 non-cem.Patient health status is not known.

Manufacturer Narrative

Internal complaint reference number: case-(b)(4).

Manufacturer Narrative

H3, h6: it was reported that, after a left tha had been performed on (b)(6) 2003, the patient suffered a dislocation/subluxation.This event was addressed via revision surgery on 16-(b)(6) 2007.This information was provided by the national joint registry of the united kingdom.The device intended for use in treatment was not returned for investigation.An evaluation of the complained device could therefore not be conducted and the reported failure mode could not independently be confirmed.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported issue.A review of the complaint history revealed no additional complaint for the batch in question.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Review of past corrective actions was performed.No further escalation is required.The ifu (lit.No.12.23 ed 03/21 & lit.No.5010100 12/03) lists dislocation as known possible side effect/ complication resulting from a hip arthroplasty.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.Based on available information, the reported failure mode cannot be confirmed.A relationship between the reported event and the device cannot be confirmed.There is no indication that the reported device 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.The root cause for the reported dislocation is stays undetermined.The need for corrective action is not indicated.This complaint will be reopened should additional information or the device be received.

• Brand Name: BICON-PLUS PE INSERT ANTIL 3/28 NON-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: 13829748
• MDR Text Key: 287848669
• Report Number: 9613369-2022-00053
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K992154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 75003579
• Device Lot Number: 0305.60.1092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female