MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG BICON-PLUS PE INSERT STD 4/32 NON-CEM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 75003554

Device Problem Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Synovitis (2094)

Event Date 09/02/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that, after a tha had been performed on (b)(6) 2001, the patient experienced synovitis.A percutaneous biopsy was taken on (b)(6) 2015, which revealed that there was not any infection.A revision surgery was performed on (b)(6) 2015 to exchange the bearings: both the bicon-plus pe insert and the ceramic ball head were explanted and replaced by another bicon-plus pe insert and by a bioball head and adapter.Intra-operatively it was found that the liner was worn and that the head was decentered as consequence.Patient recovered successfully.

Manufacturer Narrative

Results of investigation: it was reported that, after a total hip arthroplasty had been performed on 28-feb-2001, the patient experienced synovitis.A percutaneous biopsy was taken on 02-sep-2015, which revealed that there was not any infection.A revision surgery was performed on 03-sep-2015 to exchange the bearings: both the bicon-plus pe insert and the ceramic ball head were explanted and replaced by another bicon-plus pe insert and by a bioball head and adapter.Intra-operatively it was found that the liner was worn and that the head was decentered.The device, used in treatment, was not returned for investigation.A product evaluation could therefore not be performed.Nevertheless, the batch number is known and a review of the batch record could be performed.The device was manufactured in year 2000.No deviations from the standard manufacturing process were reported which could have contributed to the reported issue.Hence, there is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.A complaint history review was performed as well.No additional complaint for the batch in scope was reported so far.The occurence and severity are in line with the corresponding risk file.A review of past corrective actions was performed.No further escalation is required.The severity and the failure mode are covered through the smith and nephew risk management.According to the performed medical assessment, it cannot be determined that the reported clinical symptoms are associated with a malperformance of the implant or implant failure vs 14 year time implanted or other patient factors.The patient impact beyond the reported revision cannot be determined.No further clinical assessment is warranted at this time.A review of the device labeling revealed that the ifu (lit.No.Lit.No.12.23, ed.03/21) states wear and loosening of the component as a possible risk factor in combination with the implantation of a hip prosthesis.Based on the performed investigations, a relationship between the reported event and the device cannot be confirmed and the root cause of the reported issue remains undetermined.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event.No further actions are deemed necessary at this time.Smith+nephew will continue to monitor this device for similar issues.The returned device will be archived.

• Brand Name: BICON-PLUS PE INSERT STD 4/32 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: 13722468
• MDR Text Key: 286948376
• Report Number: 9613369-2022-00049
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K992154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 75003554
• Device Lot Number: 0010.52.1960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• 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
• Treatment: 75002704, SL-PLUS STANDARD STEM, 0012.13.4062; 75003741, BICON-PLUS SHELL, 0011.13.4086; 75004174, CERAMIC BALL HEAD, 0009.15.3041
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male