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 Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/30/2015

Event Type  Injury  

Event Description

On the literature article named "ten to fifteen-year clinical and radiographic follow-up with a third-generation cementless stem in a young patient population", it was reported that, after a bicon-plus shell had been implanted on 1 patient, patient # 14 of the study, a revision surgery was performed 0, 1 years after the primary surgery due to mispositioning of the cup.The bicon cup and insert were explanted.Patient outcome is unknown.

Manufacturer Narrative

The study of studers p.[1] reports 311 primary thas performed in 276 patients between 1996 and 2000 using a sl-plus stem.8 cases required revision of a bicon component.On patient #14, a revision surgery was performed 0,1 years after the primary surgery due to mispositioning of the cup.The bicon cup and insert were explanted.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.The 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 ifu 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 our investigations the failure mode cannot be confirmed.A relationship between the reported event and the device cannot be confirmed.Due to insufficient information it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution and 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]: studers p, belajevs d, jurkevics v, likums p.Ten to fifteen-year clinical and radiographic follow-up with a third-generation cementless stem in a young patient population.Int orthop.2016 mar;40(3):465-71.Doi: 10.1007/s00264-015-2846-z.Epub 2015 jul 30.Pmid: 26224612.

• 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: 11845535
• MDR Text Key: 251370979
• Report Number: 9613369-2021-00236
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• 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: 06/17/2021

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: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention