MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. BICON-PLUS SHELL; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number UNKN1100402

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

Patient Problems Bacterial Infection (1735); Pain (1994); Loss of Range of Motion (2032)

Event Date 01/10/2020

Event Type  Injury  

Event Description

On the literature article named "unique migration of a septic loosened metal-on-metalcementless total hip arthroplasty: a case report and literature review", it was reported that, the patient was admitted to the author's department with hip and tight pain associated with the inability to full weight bearing on the right leg.Sclerotic, osteolytic lesions, associated with perforation of the lateral and medial cortices of the proximal femur and migration to 90-degree horizontal position on the frontal plane of the whole prosthesis, following chronic deep infection and fistula formation.Based on the preoperative planning, the implants were removed through a small medial longitudinal approach accompanied with lateral debridement.The patient denied revision surgery and the final result was a resection arthroplasty.The outcome of the patient was good.

Manufacturer Narrative

H3, h6: the study of papaioannou i [1] reports a unique migration of a septic loosened metal-on-metal cementless total hip arthroplasty.A revision was conducted including an unknown bicon plus shell.The complaint device, used in treatment, was not returned for investigation, hence the product evaluation could not be conducted.A complaint history review was performed.The batch record review could not be performed as the batch number of the device is not known.Severity and the failure mode are covered through our risk management.The reported failure mode might occur in some cases, which is stated as a side effect in the instructions for use lit.No.12.23 ed.05/16.No patient information nor any other medication documentation was provided, therefore, a thorough medical investigation could not be performed.Based on the conducted investigation the failure mode could not be confirmed independently.A relationship between the reported event and the device cannot be confirmed.Due to insufficient information it is neither possible to investigate whether the reported device met manufacturing specifications upon release for distribution nor to speculate about factors which could have contributed to the reported event.The root cause of the problem stays undetermined.To date, no further actions will be taken.Smith and nephew will monitor the devices for further similar issues.This investigation is considered closed.[1]: papaioannou i, ntourantonis d, baikousis a, syrimpeis v, korovessis p.Unique migration of a septic loosened metal-on-metalcementless total hip arthroplasty: a case report and literature review.Journal of orthopaedic case reports 2020 jan-feb;10(1): 93-97.

• Brand Name: UNKN. BICON-PLUS SHELL
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11845532
• MDR Text Key: 251389044
• Report Number: 9613369-2021-00233
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN1100402
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 52 YR