MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM COLLAR LAT. TI/HA 8; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number	75018419
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that during a thr, while opening the polarstem collar lat.Ti/ha 8, the inner package was not sealed causing implant to fall off of sterile field.Surgery was performed, without any delay, with a back-up device.No patient complications were reported.
Additional Manufacturer Narrative
H3, h6: it was reported that during a total hip replacement (thr), while opening the polarstem collar lat.Ti/ha 8, the inner package was not sealed causing implant to fall off of sterile field.Surgery was performed, without any delay, with a back-up device.No patient complications were reported.The complaint sample was not returned for evaluation, so the visual evaluation was performed based on the provided photos from the complainant.Upon visual inspection, the reported failure cannot be confirmed as the provided photo is only showing the outer packaging with the labelling.No statement pertaining the inner packaging can be rendered.The production documentation was reviewed, no deviations from the standard manufacturing procedure contributing to the reported failure were found.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 past corrective actions was performed.No further escalation is required.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.A review of the device labeling revealed that the current ifu (lit.No.12.23, ed.03/21) states that "implants where the packaging and/or labelling is damaged or not intact, may not be implanted".Based on the available information and the performed investigation, the reported failure could not be confirmed.A relationship between the reported event and the device cannot be confirmed.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event.The root cause remains undetermined.Should the device or additional information be received, the complaint will be reopened.Smith and nephew will continue to monitor this device for similar issues.This investigation is considered closed.

• Brand Name: POLARSTEM COLLAR LAT. TI/HA 8
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: 18065189
• Report Number: 9613369-2023-00209
• Device Sequence Number: 7758859
• Product Code: MEH
• UDI-Device Identifier: 07611996103564
• UDI-Public: 07611996103564
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143739
• 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): 11/23/2023

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: 12/12/2025
• Device Catalogue Number: 75018419
• Device Lot Number: B1822296
• 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: 10/12/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 11/23/2023
• Date Device Manufactured: 12/14/2018
• 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