MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM LAT.TI/HA 2 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Model Number	75100475
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint reference: case (b)(4).
Event or Problem Description
It was reported that during a thr procedure, a problem has been detected regarding packaging with loss of sterility.The last plastic of this stem was opened in the distal part, so the surgeon decided not to use the device.Surgery was delayed for no more than 30 min.
Additional Manufacturer Narrative
Results of investigation: it was reported that during a total hip replacement procedure, a problem has been detected regarding packaging with loss of sterility.The last peel bag of a polarstem stem lat.Ti/ha 2 non-cem was opened in the distal part.The claimed article, which intent use is in treatment, including damaged packaging was not returned for investigation.On picture was provided.The picture shows the polarstem stem in the innermost bag.There are traces of blood on the label.Another bag is lying next to it.It appears that the innermost bag has been opened at the seams sealed for this purpose.According to the complaint description, the last plastic bag of this stem was opened in the distal part.According to the picture given this statement can not be confirmed.In order to be able to make a statement on the basis of pictures, these must show the problem in more detail.Ideally, the claimed packaging should be returned for detailed examination.A product history review reveal no deviations that could explain the occurred failure.Without the specific article including packaging or more detailed pictures the reported failure can not be confirmed and the root cause remains undetermined.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 (ifu lit.No.12.23 ed.05/16) 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.Smith&nephew will however continue to monitor the corresponding products for similar issues.

• Brand Name: POLARSTEM STEM LAT.TI/HA 2 NON-CEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11009068
• Report Number: 9613369-2020-00257
• Device Sequence Number: 3595055
• Product Code: LWJ
• UDI-Device Identifier: 07611996118667
• UDI-Public: 07611996118667
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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 Model Number: 75100475
• Device Catalogue Number: 75100475
• Device Lot Number: B2012935
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1