MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKNOWN CPS-PLUS STEM/CENTRALIZER; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Model Number UNKNOWN

Device Problem Fracture (1260)

Patient Problem Hip Fracture (2349)

Event Date 01/01/2018

Event Type  Injury  

Event Description

It was reported by the healthcare facility a cps plus fracture due to fatigue.

Event Description

It was reported by the healthcare facility a cps plus fracture.No more information was provided after several unsuccessful attempts.

Manufacturer Narrative

The fracture of a cps-plus stem was reported.No part was returned for investigation.No batch number was communicated, no review of similar complaints or of the production records could be performed.No medical documents were communicated.Based on the available information, no thorough investigation could be performed and the root cause of the reported issue remains undetermined.Smith&nephew will continue to monitor this device for similar issues.If the explants or additional information becomes available in the future this investigation will be reopened.

• Brand Name: UNKNOWN CPS-PLUS STEM/CENTRALIZER
• 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: 7998370
• MDR Text Key: 124790636
• Report Number: 9613369-2018-00077
• 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: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention