MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. FRACTURE HEAD; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number UNKNOWN

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

Patient Problem Insufficient Information (4580)

Event Date 12/09/2020

Event Type  Injury  

Event Description

It was reported that, according to the (b)(6) registry annual report, about hip and knee replacement results between 2012 ¿2019, it was found that an unknown fracture head was revised on 2 patients due to unknown reasons.Further information is not available.

Manufacturer Narrative

The siris report of 2020 reports data from hip and knee replacements between 2012-2019.Revisions were reported due to several reasons.The leading causes were aseptic loosening of the femoral or acetabular component, infection, periprosthetic fractures and dislocations.The implants, used in treatment, were not returned for investigation.This specific complaint reports 2 revisions of a fracture head.The heads were implanted in combination with cs-plus stems.The part and batch numbers were not communicated.Therefore, a thorough complaint investigation was not possible.The production documentation as well as the complaint history review could not be reviewed.The risk of a revision is covered through our risk management review, as well as through our ifu lit.No.12.23 ed (b)(6).No patient information nor any other medication documentation was provided, therefore, a thorough medical investigation could not be performed.Based on our investigations the root cause of the reported revision stays undetermined due to insufficient information.To date, no further actions will be taken.Smith and nephew will monitor the devices for further similar issues.

• Brand Name: UNKN. FRACTURE HEAD
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11136177
• MDR Text Key: 225745911
• Report Number: 9613369-2021-00018
• Device Sequence Number: 1
• Product Code: KWL
• 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: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 01/28/2021
• Supplement Dates FDA Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention