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

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

It was reported that a patient had fractured her femur in a motorcycle accident.

Manufacturer Narrative

It was reported that a patient had fractured her femur implanted with an unknown polarstem implant in a motorcycle accident.The complaint device, used in treatment, was not returned for investigation.The complaint history review and production documentation review could not performed since the batch number of the complaint device is unknown.The risk management review could verify the severity and expected occurrence of the reported issue.The device labeling was reviewed.It is stated that femoral fracture is a known risk factor in combination with the implantation of a hip prosthesis.For the medical investigation, no patient specific information has been provided to support the complaint.Without supporting clinical documents, the medical investigation cannot be performed.Based on the conducted complaint investigation, the root cause remains undetermined after investigation.It cannot be excluded that the reported trauma contributed to present issue.There is however, no indication that the stem failed to match specification at the time of manufacturing.The complaint will be reopened if additional information will become available.Smith+nephew will continue to monitor this device for similar issues.

• Brand Name: POLARSTEM (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: 9568441
• MDR Text Key: 174278173
• Report Number: 9613369-2020-00009
• 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: 03/25/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/23/2019
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 12/23/2019
• Supplement Dates FDA Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening