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

Device Problem Pitted (1460)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

It was reported that a revision surgery of polar stem with cocr heads was performed due to taper corrosion.

Manufacturer Narrative

Results of investigation: an unknown polarstem was reported due taper corrosion which led to revision surgery with a cocr head.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 unclear.The risk management review could verify the severity and expected occurrence of the reported issue.The device labeling was reviewed.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 could not be determined conclusively.The complaint will be reopened if additional information will become available.Smith+nephew will continue to monitor for similar issues.

• Brand Name: POLARSTEM
• 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: 9445992
• MDR Text Key: 170109635
• Report Number: 9613369-2019-00101
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN COCR BALLHEAD