MAUDE Adverse Event Report: SMITH & NEPHEW, INC. POLARSTEM STEM STD TI/HA 3 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Model Number 75100466

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

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 07/15/2020

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to anterior dislocation.The surgeon does not fault implants and believes that patient had abnormal femoral anatomy that contributed to this.No x-ray available.

Manufacturer Narrative

A revision surgery was performed due to anterior dislocation.The claimed article is a polarstem ti/ha size 3 stem [article no.: 75100466], which intent use is in treatment.The stem wasn't returned for investigation.Also no clinical documentation was provided.A product history review was performed, but no deviation was found which could lead to the reported issue.Neither for the reported batch number nor for this specific article no other complaint can be found with similar failure mode.Therefore, a manufacturing or production error is not assumed.In our instruction for use for hip implants 12.23 ed.05/16 dislocation is a possible and named side effect of a tep.At the moment the root cause can not be determined.Should further information or the product get available this case will be reassigend.Smith + nephew will monitor this device for similar issues.

• Brand Name: POLARSTEM STEM STD TI/HA 3 NON-CEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10393470
• MDR Text Key: 202502270
• Report Number: 1020279-2020-03836
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 07611996118575
• UDI-Public: 07611996118575
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 10/05/2020

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
• Device Model Number: 75100466
• Device Catalogue Number: 75100466
• Device Lot Number: B1814390
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 08/11/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention