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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/18/2020

Event Type  Injury  

Event Description

It was reported a revision surgery was performed.Originally, the reason for the revision was to replace the liner due to wear/migration.When the liner did not fit, surgeon hit the liner so hard in the bicon cup that the backside of the acetabulum broke out.Therefore, they have to revise the hole acetabulum (head and cup) and the procedure was delayed for over 2 hours.Additionally, the stem has also broken out during surgery.Thus, liner, stem, head and cup were exchanged.All of them are s+n but only bicon cup and sl plus with family identified.

Manufacturer Narrative

It was reported that a revision surgery was performed due to wear and migration of the liner.When the surgeon was inserting the new liner, it did not fit perfectly.Therefore, he hit the liner so hard that a bicon cup broke through the acetabulum.As the stem also loosened due to this interaction, the stem and the ball head were also revised.No part and batch numbers were made available.Also the parts, used in treatment, were not returned for investigation.An x-ray was provided.A medical assessment concludes, that the femoral head does not sit centered within the cup, which supports the initial reason for the revision surgery.However, the root cause of the wear of the liner cannot be determined.As no batch and part number were communicated, a batch record review and a complaint history review could not be performed.The severity and the failure mode are covered through the risk management files.Wear of an implant is a possible risk factor, mentioned in the ifu lit.No.12.23 ed.05/16.To date, the need for further actions is not given.The root cause stay undetermined after investigation, the failure mode can be confirmed based on the provided x-ray.Smith and nephew will monitor these devices for similar issues.

• Brand Name: UNKN. BICON-PLUS INSERT (UNKN. TYPE)
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 9812270
• MDR Text Key: 182757066
• Report Number: 9613369-2020-00055
• 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: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention