MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM LAT.TI/HA 8 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	75100481
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during thr surgery, the sterility of one (1) polarstem stem lat.Ti/ha 8 non-cem was in question so it was not implanted after being opened.There were holes identified in the packaging.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
H3, h6: it was reported that, during a total hip replacement surgery, the sterility of one (1) polarstem stem lat.Ti/ha 8 non-cem was in question so it was not implanted after being opened.There were holes identified in the packaging.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not injured as consequence of this problem.The device intended for use in treatment was not returned for investigation.A product evaluation was not possible.A review of the production, packaging and sterilization documentation did not detect any deviation that could have contributed to the reported failure mode.The review of historical complaints for the alleged device revealed no additional similar complaints reported for the same batch, and no additional similar complaints for the same product number over the past 12 months with similar failure mode.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.Previous investigations demonstrated that the performance of the device is within the risks level that are anticipated in the risk management documentation.As part of the continuous improvement, smith + nephew is planning a packaging design enhancement.No further escalation is required.The performed investigation does not lead to an accurately determined cause.There is no indication that the reported devices failed to meet manufacturing specifications upon release for distribution.Due to insufficient information and the device not being returned, it is not possible to indicate factors which could have contributed to the reported event.There is no need for further actions because of the limited information provided.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.

• Brand Name: POLARSTEM STEM LAT.TI/HA 8 NON-CEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18393572
• Report Number: 9613369-2023-00227
• Device Sequence Number: 18280038
• Product Code: LZO
• UDI-Device Identifier: 07611996118728
• UDI-Public: 07611996118728
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2024

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 Catalogue Number: 75100481
• Device Lot Number: B2013176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown