MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 5 NON-CEM; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	75100468
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the polarstem stem std ti/ha 5 non-cem had powdery residue left inside packaging.Surgeon was notified but happy to use implant.The procedure was completed, with a delay (less than 30 minutes), using the same device.No patient injuries and no other complications were reported.
Additional Manufacturer Narrative
H3, h6: it was reported that during surgery, the polarstem stem std ti/ha 5 non-cem had powdery residue left inside packaging.Surgeon was notified but happy to use implant.The procedure was completed, with a delay (less than 30 minutes) , using the same device.No patient injuries and no other complications were reported.The device was not returned due to the fact that the surgeon decided to use the implant.A picture was provided which shows the stem within the innermost peel bag.It can clearly be seen that the stem is not fixed properly in this pouch any more.The bag has some scratches on the inside due to a possible movement of the stem due to missing vacuum.No other damage can be seen.The seal seams are closed and no hole or rip is visible.A packaging problem could be identified due to this given picture and the relationship between reported event and device can be confirmed.A review of the production records did not reveal any deviations which relate to the occurred failure.A complaint review was performed, for the specific batch number no other complaint can be found.Therefore, it will not assumed that the device failed specification at time of manufacturing.It can only be assumed that repeated stock manipulations may have contributed to the motion of the stem inside the packaging causing the observed sterility breach.According to our instructions for use implants may not be implanted under any circumstances if the packaging is damaged or not intact.Peel pouches showing scratches or significant migration of the stem towards the sealed seams as well as stems observed to move freely inside the peel pouches or should therefore be considered as unfit for use.If this scenario occurs, we kindly ask you to return the affected products (the peel pouches and the corresponding stems) to the appropriate smith & nephew representative or office for investigation.This complaint will be closed.To date no corrective or preventive actions are planned.Smith&nephew will however continue to monitor the corresponding products for similar issues.

• Brand Name: POLARSTEM STEM STD TI/HA 5 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: 11907558
• Report Number: 9613369-2021-00272
• Device Sequence Number: 3588759
• Product Code: LZO
• UDI-Device Identifier: 07611996118599
• UDI-Public: 07611996118599
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

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: 11/20/2025
• Device Model Number: 75100468
• Device Catalogue Number: 75100468
• Device Lot Number: 1820766
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 05/31/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1