MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP SHELL TI-PLASMA/HA 55 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	75100442
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a thr surgery, in one (1) polarcup shell ti-plasma/ha 55 non-cem the locking screw does not come off.The procedure was resumed, after a significant delay, with a s+n back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Section h10: it was reported that during a total hip replacement (thr) surgery, in one (1) polarcup shell ti-plasma/ha 55 non-cem the locking screw does not come off.The procedure was resumed, after a significant delay, with a s+n back-up device.Patient was not injured as consequence of this problem.The complaint sample was returned for investigation.Upon visual inspection, the remaining screw head appeared to be heavily damaged.The other screw has been unscrewed and this screw head appears to be intact.The review of historical complaints for the alleged device revealed no additional similar complaints reported for the same batch, and additional similar complaints for the same product number over the past 12 months with similar failure mode.A review of the product documentation did not detect any deviation that could have contributed to the reported 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.Based on the available information and the performed investigation, the complaint could be confirmed.The root cause for the reported jamming cannot clearly be identified and stays undetermined.The surgical technique (lit no.01620-en (1582) v8 10/21) describes the correct removal of the polarcup plugs using the unidirectional t handle (75023347): "release the plugs by turning the t-wrench in the direction indicated on the plug cover." a worn t-handle is known to contribute to the reported event.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all devices must be inspected and controlled for proper functioning after cleaning/disinfection.The need for corrective action is not indicated.Smith+nephew will continue to monitor this device for similar issues.The returned complaint sample will be scrapped.Internal complaint reference number: (b)(4).

• Brand Name: POLARCUP SHELL TI-PLASMA/HA 55 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: 17939379
• Report Number: 9613369-2023-00201
• Device Sequence Number: 6352264
• Product Code: LZO
• UDI-Device Identifier: 07611996118339
• UDI-Public: 07611996118339
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K122244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

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 Catalogue Number: 75100442
• Device Lot Number: B2124432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown