MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP XLPE INSERT 43/22 NON-CEM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number	75018942
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference number: (b)(4) h10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.
Event or Problem Description
It was reported that during thr surgery one (1) polarcup xlpe insert 43/22 non-cem was placed in the press with the 22 head.It seemed to have created a vacuum, as the head moved inside the insert and appeared to be fine.However, when placing the insert on the patient and reducing it, the insert came loose from the head.They had to remove the head from the stem.The process of inserting the head into the insert was repeated, and when reducing it again, the exact same issue occurred.The treatment was resumed after a significant delay, using a s+n back-up device, which was implanted correctly.No injuries were reported as a consequence of this issue.
Additional Manufacturer Narrative
It was reported that during total hip replacement surgery one (1) polarcup xlpe insert 43/22 non-cem was placed in the press with the 22 head.It seemed to have created a vacuum, as the head moved inside the insert and appeared to be fine.However, when placing the insert on the patient and reducing it, the insert came loose from the head.They had to remove the head from the stem.The process of inserting the head into the insert was repeated, and when reducing it again, the exact same issue occurred.The treatment was resumed after a significant delay, using a s+n back-up device, which was implanted correctly.The device intended for use in treatment was not returned for investigation.A product evaluation was not possible.A review of the production 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.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.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.There is no need for further actions.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: POLARCUP XLPE INSERT 43/22 NON-CEM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR 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: 19084373
• Report Number: 9613369-2024-00036
• Device Sequence Number: 15524735
• Product Code: KWY
• UDI-Device Identifier: 07611996111323
• UDI-Public: 07611996111323
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K110135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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: 75018942
• Device Lot Number: B2315699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 05/08/2024
• Date Device Manufactured: 08/03/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown