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
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9613369-2021-00092
• Device Sequence Number: 3853392
• Product Code: LZO
• UDI-Device Identifier: 07611996118728
• UDI-Public: 07611996118728
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 02/07/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1