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

Device Problem Fracture (1260)

Patient Problem Hip Fracture (2349)

Event Date 02/10/2014

Event Type  Injury  

Event Description

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

Manufacturer Narrative

Please disregard this mdr, as this is a duplicate of 9613369-2014-00036 reported in march 5, 2014.

• 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: 7998335
• MDR Text Key: 124790542
• Report Number: 9613369-2018-00076
• 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: 11/13/2018

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
• 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