MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM LAT.TI/HA 1 NON-CEM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number	75100474
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference (b)(4).
Event or Problem Description
It was reported that after a thr performed on (b)(6) 2022, the patient had an infection.A revision surgery was addressed to explant all the implants (oxonium fem hd 12/14 32 mm +4, r3 20 deg xlpe acet lnr 36 mm x 52 mm, r3 0 hole ha ctd acet shell 52 mm, ref interfit thrd hole cover and polarstem stem lat.Ti/ha 1 non-cem) and insert cement spacers.Further information is unknown at the moment.
Additional Manufacturer Narrative
It was reported that after a thr performed on (b)(6) 2022, the patient had an infection.A revision surgery was addressed to explant all the implants (oxinium fem hd 12/14 32mm +4, r3 20 deg xlpe acet lnr 36mm x 52mm, r3 0 hole ha ctd acet shell 52mm, ref interfit thrd hole cover and polarstem stem lat.Ti/ha 1 non-cem) and insert cement spacers.The device intended for use in treatment was not returned for investigation.A product evaluation was not possible.So, the mentioned failure mode can not be confirmed.A review of the production documentation did not show any deviations from the standard manufacturing procedure.The performed complaint history review for the complaint device revealed no previous complaints for the same batch.A review of past corrective actions was performed.No further escalation is required.A review of the risk management documentation verifies the failure mode and severity of the reported issue.A review of the device labeling revealed that the ifu (lit.No.12.23 ed.03/21) states infections of the component as a ¿potential adverse device effects¿ in combination with the implantation of a hip prosthesis.As the requested clinical documentation has not been provided, no clinical factors were found which would have contributed to the infection.Based on the information provided to the complaint, it is not possible to confirm the reported failure mode.A relationship between the reported event and the device cannot be confirmed and the root cause of the reported issue remains undetermined.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event.There is no need for corrective action 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 1 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: 15274468
• Report Number: 9613369-2022-00472
• Device Sequence Number: 12345039
• Product Code: KWY
• UDI-Device Identifier: 07611996118650
• UDI-Public: 07611996118650
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 75100474
• Device Catalogue Number: 75100474
• Device Lot Number: C2135241
• 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: 08/04/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 09/29/2022
• Date Device Manufactured: 07/08/2021
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown