MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP SHELL 61 CEMENTED; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	75100460
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a thr, it was noticed that the outer wrap of one polarcup shell 61 cemented was intact but the inner packaging was open, leaving the implant unsterile.The procedure was performed, after a non-significant delay, with a s+n back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Section h3, h6: it was reported that, during a total hip replacement surgery, it was noticed that the outer wrap of one (1) polarcup shell 61 cemented was intact but the inner packaging was open, leaving the implant unsterile.The complaint polarcup device was returned for investigation.However, the device was not returned with any packaging material.The reported failure mode could therefore not be confirmed.The polarcup device itself looks intact.The production documentation at the internal production as well as at the external packaging supplier site was reviewed.No deviations from the standard manufacturing procedure were detected.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.No additional complaints for the affected batch nor additional complaints for the same product number were found.A review of the risk management documentation verifies the failure mode, occurrence, and severity of the reported issue.In our current instruction for use for hip implants lit.12.23 ed.03/21 it is mentioned that the device should not be used if the packaging shows any damage.A review of past corrective actions was performed.No further escalation is required.Due to the missing packaging components, it is not possible to speculate about factors which could have contributed to the reported issue.Based on the performed investigations, no problem could be detected and no further actions will be taken to this date.Should additional information become available, this complaint will be reassessed.Smith and nephew will monitor the devices for further similar issues.

• Brand Name: POLARCUP SHELL 61 CEMENTED
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 16135810
• Report Number: 9613369-2023-00003
• Device Sequence Number: 17818593
• Product Code: LPH
• UDI-Device Identifier: 07611996118513
• UDI-Public: 07611996118513
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K110135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2023

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: 03/26/2024
• Device Model Number: 75100460
• Device Catalogue Number: 75100460
• Device Lot Number: B1704745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2022
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2017
• 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