MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM LAT.TI/HA 8 NON-CEM; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number 75100481

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2021

Event Type  malfunction  

Event Description

It was reported that, during the preparation of the material for surgery, when the stem was removed from the packaging, it was found that the innermost packaging level did not have a vacuum or was sealed.The product was not used due to the risk of not being sterile.The procedure was completed using a s+n backup device.No surgical delay or injury to the patient was reported.

Manufacturer Narrative

Results of investigation: it was reported that, during the preparation of the material for surgery, when a polarstem lateral ti/ha size 8 was removed from the packaging, it was found that the innermost packaging level did not have a vacuum or was even sealed.The product was not used due to the risk of not being sterile.The procedure was completed using a s+n backup device.To date the claimed article, which intent use is in treatment, including damaged or inproper sealed packaging was not returned for investigation.In this case this would be quite helpful to fully investigate the case.However, a product history review was performed.The corresponding batch record did not reveal any deviation which could explain the occurred failure of the device.For the reported batch number no other complaint can be found.The risk of an unsealed device packaging is covered in our corresponding risk file and rated as low.In our current instruction for use for hip implants lit.12.23 ed.05/16 it is mentioned that the device should not be used if the packaging shows any damage.Should the article get available in future this case will be re-assigned.S+n will monitor this device for similar issues.

• Brand Name: POLARSTEM STEM LAT.TI/HA 8 NON-CEM
• Type of Device: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11409074
• MDR Text Key: 234809606
• Report Number: 9613369-2021-00092
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07611996118728
• UDI-Public: 07611996118728
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• 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: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2022
• Device Model Number: 75100481
• Device Catalogue Number: 75100481
• Device Lot Number: B1508861
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/07/2021
• Initial Date FDA Received: 03/04/2021
• Supplement Dates Manufacturer Received: 04/15/2021
• Supplement Dates FDA Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1